510(k) Report

510(k) · Cleared

Cleared

Intellivue Patient Monitor

K113657510(k) TraditionalCleared Mar 22, 2012101-day reviewClass II21 CFR 870.1025

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Philips Medizin Systeme Boblingen GmbH · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Mar 22, 2012 as substantially equivalent to K110622 (Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, 2011) and 33 other predicates after a 101-day review. Its family tree reaches back 31 generations to 1994. 81 later devices descend from it.

Decided
Mar 22, 2012
Review
101 days
Class
Class II
Product code
MHX
Recalls
None
Predicates
34

Its longest line of descent runs back 31 generations to K941811 (1994). 185 ancestors in all, the oldest K844187 (1985). 81 later devices descend from it, 10 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 2 other ancestors2008: 2 other ancestors2007: 2 other ancestors2006: 5 other ancestors2004: 13 other ancestors2003: 12 other ancestors2005: 2 other ancestors2002: 14 other ancestors2001: 8 other ancestors2000: 19 other ancestors1999: 10 other ancestors1998: 13 other ancestors1997: 7 other ancestors1996: 10 other ancestors1992: 6 other ancestors1989: 2 other ancestors1995: 6 other ancestors1994: 2 other ancestors1993: 5 other ancestors1991: 6 other ancestors1990: 6 other ancestors1987: 1 other ancestor1985: 1 other ancestor2014: 2 descendants cleared2013: 5 descendants cleared2016: 3 descendants cleared2012: 1 descendant cleared2015: 3 descendants cleared2023: 10 descendants cleared2020: 4 descendants cleared2022: 8 descendants cleared2017: 4 descendants cleared2018: 6 descendants cleared2019: 6 descendants cleared2021: 4 descendants cleared2025: 12 descendants cleared2024: 7 descendants cleared2026: 6 descendants clearedK941811 · HP M1175A, M1176A, Component Monitoring System · Hewlett-Packard Co. · 1994K960934 · HP M1205A Omnicare Component Monitor System Model 24 · Hewlett-Packard Co. · 1996×3: 3 generations cleared close together, K981376 (1999), K990125 (1999), K990972 (1999) ×9: 9 generations cleared close together, K013199 (2001), K020531 (2002), K021778 (2002), K023871 (2002), K030038 (2003), K031481 (2003), K032858 (2003), K040304 (2004), K041235 (2004) ×11: 11 generations cleared close together, K042845 (2004), K050141 (2005), K050762 (2005), K051106 (2005), K052801 (2005), K053522 (2006), K060221 (2006), K060541 (2006), K061052 (2006), K061610 (2006), K063315 (2006) K071426 · MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient Monitors · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007K083517 · Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, and MP90 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · recalledK091927 · Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009×2: 2 generations cleared close together, K100939 (2010), K101449 (2010) K110622 · Intellivue Patient Monitor · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 10 other ancestors2 generations back: 30 other ancestors3 generations back: 49 other ancestors4 generations back: 27 other ancestors5 generations back: 17 other ancestors6 generations back: 12 other ancestors7 generations back: 8 other ancestors8 generations back: 1 other ancestor 1 generation forward: 10 descendants2 generations forward: 8 descendants3 generations forward: 19 descendants4 generations forward: 11 descendants5 generations forward: 11 descendants6 generations forward: 8 descendants7 generations forward: 8 descendants8 generations forward: 6 descendants K110622 · Intellivue Patient Monitor · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · recalledK101449 · Intellivue Patient Monitor · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010K100939 · Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 and MP90 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010K091927 · Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009K083517 · Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, and MP90 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · recalledK071426 · MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient Monitors · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007K063315 · Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 · Philips Medizin Systeme Boeblingen GmbH · 2006K061610 · Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2006K061052 · The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90 · Philips Medical Systems North America, Inc. · 2006K060541 · The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient Monitors · Philips Medizin Systeme Boblingen GmbH · 2006 · recalledK060221 · The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2006K053522 · Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00 · Philips Medizin Systeme Boeblingen GmbH · 2006K052801 · Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 · Philips Medizin Systeme Boeblingen GmbH · 2005K051106 · The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2005K050762 · Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90 · Philips Medizin Systeme Boeblingen GmbH · 2005K050141 · The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2005K042845 · The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boblingen GmbH · 2004K041235 · Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2004K040304 · Philips Intellivue Patient Monitor, Models MP40 & MP50 · Philips Medizin Systeme Boeblingen GmbH · 2004K032858 · The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O. · Philips Medizin Systeme Boblingen GmbH · 2003K031481 · The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 · Philips Medizin Systeme Boblingen GmbH · 2003K030038 · Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185 Opt C41 Wireless Bedside Adaptr · Philips Medical Systems, Inc. · 2003K023871 · M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue Patient Monitor with Portal Technology · Philips Medical Systems · 2002K021778 · Philips Component Compact Monitor, Release a.04, Model #M1275B · Philips Medical Systems · 2002K020531 · Philips Multi-Parameter Module, Model M3001A; Philips Component Compact Monitor, Release a.02, Model M1275B · Philips Medical Systems · 2002K013199 · Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276B · Philips Medical Systems, Inc. · 2001K990972 · HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia Multi-Measurement Server and Compact Portable T · Hewlett-Packard GmbH · 1999K990125 · HP Viridia Component Monitoring System, Model Rev. K · Hewlett-Packard GmbH · 1999K981376 · Hewlett-Packard M1205A Viridia 24 CT · Hewlett-Packard Co. · 1999K960934 · HP M1205A Omnicare Component Monitor System Model 24 · Hewlett-Packard Co. · 1996K941811 · HP M1175A, M1176A, Component Monitoring System · Hewlett-Packard Co. · 1994−30−25−20−15−10−50+5
  1. Root · 31 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 27 generations between
  3. 3 generations backK100939 Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
  4. 2 generations backK101449 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
  5. 1 generation backK110622 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · Recalled
  6. This deviceK113657 Intellivue Patient MonitorPhilips Medizin Systeme Boblingen GmbH · 2012
  7. Descendant · cites it directly · 41 of its ownK122439 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2012 · Recalled
  8. Descendant · cites it directly · 37 of its ownK131872 Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2013 · Recalled
  9. Descendant · cites it directly · 37 of its ownK130849 Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2013 · Recalled
  10. Descendant · cites it directly · 36 of its ownK141015 Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2014 · Recalled
  11. Descendant · cites it directly · 35 of its ownK122223 New: Intellivue CL Respiration Pod New: Specialized Assessory…Philips Medizin Systeme Boeblingen GmbH · 2013
Show all 31 generations
  1. Root · 31 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 30 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
  3. 29 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
  4. 28 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
  5. 27 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  6. 26 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
  7. 25 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
  8. 24 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
  9. 23 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
  10. 22 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
  11. 21 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
  12. 20 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
  13. 19 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
  14. 18 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
  15. 17 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
  16. 16 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
  17. 15 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
  18. 14 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
  19. 13 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
  20. 12 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
  21. 11 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  22. 10 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
  23. 9 generations backK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
  24. 8 generations backK061610 Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  25. 7 generations backK063315 Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH · 2006
  26. 6 generations backK071426 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
  27. 5 generations backK083517 Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · Recalled
  28. 4 generations backK091927 Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009
  29. 3 generations backK100939 Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
  30. 2 generations backK101449 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
  31. 1 generation backK110622 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · Recalled
  32. This deviceK113657 Intellivue Patient MonitorPhilips Medizin Systeme Boblingen GmbH · 2012

Showing 5 of 81 descendants. See all descendants

Descendants cleared per year

2012: 12013: 52014: 22015: 32016: 32017: 42018: 62019: 62020: 42021: 42022: 82023: 102024: 72025: 122026: 6
2012high 12 (2025) · low 1 (2012)2026

Most influential descendants

Showing 5 of 81 · See all
  • K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2012 · cites it directly41descendants
  • K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2013 · cites it directly37descendants
  • K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2013 · cites it directly37descendants
  • K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2014 · cites it directly36descendants
  • K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH · 2013 · cites it directly35descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−31K941811HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co.1994—
−30K960934HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co.1996—
−29K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co.1999—
−28K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH1999—
−27K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
−26K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—
−25K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…Philips Medical Systems2002—
−24K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002—
−23K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…Philips Medical Systems2002—
−22K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology…Philips Medical Systems, Inc.2003—
−21K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH2003—
−20K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH2003—
−19K040304Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH2004—
−18K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2004—
−17K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient…Philips Medizin Systeme Boblingen GmbH2004—
−16K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2005—
−15K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizin Systeme Boeblingen GmbH2005—
−14K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2005—
−13K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH2005—
−12K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors…Philips Medizin Systeme Boeblingen GmbH2006—
−11K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2006—
−10K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient…Philips Medizin Systeme Boblingen GmbH20062
−9K061052The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc.2006—
−8K061610Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2006—
−7K063315Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80…Philips Medizin Systeme Boeblingen GmbH2006—
−6K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007—
−5K083517Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20092
−4K091927Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009—
−3K100939Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010—
−2K101449Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2010—
−1K110622Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20112
0 (this device)K113657Intellivue Patient MonitorPhilips Medizin Systeme Boblingen GmbH2012—
+1K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH20124
+1K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20135
+1K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20138
+1K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20141
+1K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp…Philips Medizin Systeme Boeblingen GmbH2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
198710
198920
199060
199160
199260
199350
199420
199560
1996100
199770
1998130
1999100
2000190
200180
2002140
2003120
2004130
200520
200650
200720
200820
201020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201350
201420
201530
201630
201740
201860
201960
202040
202140
202280
2023100
202470
2025120
202660
FIG. 1 — Lineage of K113657, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MHX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MHX device

  1. #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (34)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K110622Intellivue Patient Monitor
Summary page 2
…ctroencephalogram Signal 3. The modified devices are substantially equivalent to previously cleared Philips IntelliVue patient monitors marketed pursuant to K110622, K(102562, K(101449, K(100939, K(093268, K(091927, K(083517, K(082633, K(081793, K(072070, K(071426, K(063725, K(063315…
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20112
*K102562Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60…
Summary page 2
…logram Signal 3. The modified devices are substantially equivalent to previously cleared Philips IntelliVue patient monitors marketed pursuant to K110622, K(102562, K(101449, K(100939, K(093268, K(091927, K(083517, K(082633, K(081793, K(072070, K(071426, K(063725, K(063315, K(062283…
Philips Medizin Systeme Boblingen GmbH2010—
*K101449Intellivue Patient Monitor
Summary page 2
…nal 3. The modified devices are substantially equivalent to previously cleared Philips IntelliVue patient monitors marketed pursuant to K110622, K(102562, K(101449, K(100939, K(093268, K(091927, K(083517, K(082633, K(081793, K(072070, K(071426, K(063725, K(063315, K(062283, K(062392…
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010—
*K100939Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70…
Summary page 2
…The modified devices are substantially equivalent to previously cleared Philips IntelliVue patient monitors marketed pursuant to K110622, K(102562, K(101449, K(100939, K(093268, K(091927, K(083517, K(082633, K(081793, K(072070, K(071426, K(063725, K(063315, K(062283, K(062392, K(061610…
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010—
*K093268Intellivue Patient Monitor
Summary page 2
…vices are substantially equivalent to previously cleared Philips IntelliVue patient monitors marketed pursuant to K110622, K(102562, K(101449, K(100939, K(093268, K(091927, K(083517, K(082633, K(081793, K(072070, K(071426, K(063725, K(063315, K(062283, K(062392, K(061610, K(061052, K(0…
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20102
*K091927Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90
Summary page 2
…substantially equivalent to previously cleared Philips IntelliVue patient monitors marketed pursuant to K110622, K(102562, K(101449, K(100939, K(093268, K(091927, K(083517, K(082633, K(081793, K(072070, K(071426, K(063725, K(063315, K(062283, K(062392, K(061610, K(061052, K(060541,…
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009—
*K083517Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80…
Summary page 2
…lly equivalent to previously cleared Philips IntelliVue patient monitors marketed pursuant to K110622, K(102562, K(101449, K(100939, K(093268, K(091927, K(083517, K(082633, K(081793, K(072070, K(071426, K(063725, K(063315, K(062283, K(062392, K(061610, K(061052, K(060541, K(060221…
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20092
*K082633Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50…
Summary page 2
…lent to previously cleared Philips IntelliVue patient monitors marketed pursuant to K110622, K(102562, K(101449, K(100939, K(093268, K(091927, K(083517, K(082633, K(081793, K(072070, K(071426, K(063725, K(063315, K(062283, K(062392, K(061610, K(061052, K(060541, K(060221, K(053522…
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20083
*K081793Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry…
Summary page 2
…previously cleared Philips IntelliVue patient monitors marketed pursuant to K110622, K(102562, K(101449, K(100939, K(093268, K(091927, K(083517, K(082633, K(081793, K(072070, K(071426, K(063725, K(063315, K(062283, K(062392, K(061610, K(061052, K(060541, K(060221, K(053522, K(052801…
Philips Medizin Systeme Boeblingen GmbH2008—
*K072070Philips MP2 and X2 Intellivue Patient Monitors
Summary page 2
…sly cleared Philips IntelliVue patient monitors marketed pursuant to K110622, K(102562, K(101449, K(100939, K(093268, K(091927, K(083517, K(082633, K(081793, K(072070, K(071426, K(063725, K(063315, K(062283, K(062392, K(061610, K(061052, K(060541, K(060221, K(053522, K(052801, K(051106…
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007—
*K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient…
Summary page 2
…d Philips IntelliVue patient monitors marketed pursuant to K110622, K(102562, K(101449, K(100939, K(093268, K(091927, K(083517, K(082633, K(081793, K(072070, K(071426, K(063725, K(063315, K(062283, K(062392, K(061610, K(061052, K(060541, K(060221, K(053522, K(052801, K(051106, K(050762…
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007—
*K063725MP5 Intellivue Patient Monitor
Summary page 2
…liVue patient monitors marketed pursuant to K110622, K(102562, K(101449, K(100939, K(093268, K(091927, K(083517, K(082633, K(081793, K(072070, K(071426, K(063725, K(063315, K(062283, K(062392, K(061610, K(061052, K(060541, K(060221, K(053522, K(052801, K(051106, K(050762, K(050141, K(0…
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007—
*K063315Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90
Summary page 2
…ent monitors marketed pursuant to K110622, K(102562, K(101449, K(100939, K(093268, K(091927, K(083517, K(082633, K(081793, K(072070, K(071426, K(063725, K(063315, K(062283, K(062392, K(061610, K(061052, K(060541, K(060221, K(053522, K(052801, K(051106, K(050762, K(050141, K(042845,…
Philips Medizin Systeme Boeblingen GmbH2006—
*K062283The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient Monitors
Summary page 2
…rs marketed pursuant to K110622, K(102562, K(101449, K(100939, K(093268, K(091927, K(083517, K(082633, K(081793, K(072070, K(071426, K(063725, K(063315, K(062283, K(062392, K(061610, K(061052, K(060541, K(060221, K(053522, K(052801, K(051106, K(050762, K(050141, K(042845, K(041235…
Philips Medical Systems North America, Inc.2006—
*K062392Philips MP5 Intellivue Patient Monitor
Summary page 2
…rketed pursuant to K110622, K(102562, K(101449, K(100939, K(093268, K(091927, K(083517, K(082633, K(081793, K(072070, K(071426, K(063725, K(063315, K(062283, K(062392, K(061610, K(061052, K(060541, K(060221, K(053522, K(052801, K(051106, K(050762, K(050141, K(042845, K(041235, K(040304…
Philips Medizin Systeme Boeblingen GmbH2006—
*K061610Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…
Summary page 2
…suant to K110622, K(102562, K(101449, K(100939, K(093268, K(091927, K(083517, K(082633, K(081793, K(072070, K(071426, K(063725, K(063315, K(062283, K(062392, K(061610, K(061052, K(060541, K(060221, K(053522, K(052801, K(051106, K(050762, K(050141, K(042845, K(041235, K(040304, K(033513…
Philips Medizin Systeme Boeblingen GmbH2006—
*K061052The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90
Summary page 2
…110622, K(102562, K(101449, K(100939, K(093268, K(091927, K(083517, K(082633, K(081793, K(072070, K(071426, K(063725, K(063315, K(062283, K(062392, K(061610, K(061052, K(060541, K(060221, K(053522, K(052801, K(051106, K(050762, K(050141, K(042845, K(041235, K(040304, K(033513, K033444,…
Philips Medical Systems North America, Inc.2006—
*K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient Monitors
Summary page 2
…102562, K(101449, K(100939, K(093268, K(091927, K(083517, K(082633, K(081793, K(072070, K(071426, K(063725, K(063315, K(062283, K(062392, K(061610, K(061052, K(060541, K(060221, K(053522, K(052801, K(051106, K(050762, K(050141, K(042845, K(041235, K(040304, K(033513, K033444, K(032858,…
Philips Medizin Systeme Boblingen GmbH20062
*K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient…
Summary page 2
…9, K(100939, K(093268, K(091927, K(083517, K(082633, K(081793, K(072070, K(071426, K(063725, K(063315, K(062283, K(062392, K(061610, K(061052, K(060541, K(060221, K(053522, K(052801, K(051106, K(050762, K(050141, K(042845, K(041235, K(040304, K(033513, K033444, K(032858, K(031481, K(03…
Philips Medizin Systeme Boeblingen GmbH2006—
*K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00
Summary page 2
…9, K(093268, K(091927, K(083517, K(082633, K(081793, K(072070, K(071426, K(063725, K(063315, K(062283, K(062392, K(061610, K(061052, K(060541, K(060221, K(053522, K(052801, K(051106, K(050762, K(050141, K(042845, K(041235, K(040304, K(033513, K033444, K(032858, K(031481, K(030038,…
Philips Medizin Systeme Boeblingen GmbH2006—
*K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50, MP60…
Summary page 2
…093268, K(091927, K(083517, K(082633, K(081793, K(072070, K(071426, K(063725, K(063315, K(062283, K(062392, K(061610, K(061052, K(060541, K(060221, K(053522, K(052801, K(051106, K(050762, K(050141, K(042845, K(041235, K(040304, K(033513, K033444, K(032858, K(031481, K(030038, K(023871,…
Philips Medizin Systeme Boeblingen GmbH2005—
*K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors
Summary page 2
…091927, K(083517, K(082633, K(081793, K(072070, K(071426, K(063725, K(063315, K(062283, K(062392, K(061610, K(061052, K(060541, K(060221, K(053522, K(052801, K(051106, K(050762, K(050141, K(042845, K(041235, K(040304, K(033513, K033444, K(032858, K(031481, K(030038, K(023871, and K(021…
Philips Medizin Systeme Boeblingen GmbH2005—
*K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90
Summary page 2
…083517, K(082633, K(081793, K(072070, K(071426, K(063725, K(063315, K(062283, K(062392, K(061610, K(061052, K(060541, K(060221, K(053522, K(052801, K(051106, K(050762, K(050141, K(042845, K(041235, K(040304, K(033513, K033444, K(032858, K(031481, K(030038, K(023871, and K(021778…
Philips Medizin Systeme Boeblingen GmbH2005—
*K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient Monitors
Summary page 2
…082633, K(081793, K(072070, K(071426, K(063725, K(063315, K(062283, K(062392, K(061610, K(061052, K(060541, K(060221, K(053522, K(052801, K(051106, K(050762, K(050141, K(042845, K(041235, K(040304, K(033513, K033444, K(032858, K(031481, K(030038, K(023871, and K(021778…
Philips Medizin Systeme Boeblingen GmbH2005—
*K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient Monitors
Summary page 2
…081793, K(072070, K(071426, K(063725, K(063315, K(062283, K(062392, K(061610, K(061052, K(060541, K(060221, K(053522, K(052801, K(051106, K(050762, K(050141, K(042845, K(041235, K(040304, K(033513, K033444, K(032858, K(031481, K(030038, K(023871, and K(021778…
Philips Medizin Systeme Boblingen GmbH2004—
*K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors
Summary page 2
…0, K(071426, K(063725, K(063315, K(062283, K(062392, K(061610, K(061052, K(060541, K(060221, K(053522, K(052801, K(051106, K(050762, K(050141, K(042845, K(041235, K(040304, K(033513, K033444, K(032858, K(031481, K(030038, K(023871, and K(021778…
Philips Medizin Systeme Boeblingen GmbH2004—
*K040304Philips Intellivue Patient Monitor, Models MP40 & MP50
Summary page 2
…6, K(063725, K(063315, K(062283, K(062392, K(061610, K(061052, K(060541, K(060221, K(053522, K(052801, K(051106, K(050762, K(050141, K(042845, K(041235, K(040304, K(033513, K033444, K(032858, K(031481, K(030038, K(023871, and K(021778…
Philips Medizin Systeme Boeblingen GmbH2004—
*K033513Easi Ecg Algorithm
Summary page 2
…063725, K(063315, K(062283, K(062392, K(061610, K(061052, K(060541, K(060221, K(053522, K(052801, K(051106, K(050762, K(050141, K(042845, K(041235, K(040304, K(033513, K033444, K(032858, K(031481, K(030038, K(023871, and K(021778…
Philips Medical Systems2004—
*K033444Philips Medical Systems, M3012A- Hemodynamic Extension to the Multi-Measurement Server
Summary page 2
…K(063315, K(062283, K(062392, K(061610, K(061052, K(060541, K(060221, K(053522, K(052801, K(051106, K(050762, K(050141, K(042845, K(041235, K(040304, K(033513, K033444, K(032858, K(031481, K(030038, K(023871, and K(021778…
Philips Medical Systems2003—
*K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O.
Summary page 2
…(062283, K(062392, K(061610, K(061052, K(060541, K(060221, K(053522, K(052801, K(051106, K(050762, K(050141, K(042845, K(041235, K(040304, K(033513, K033444, K(032858, K(031481, K(030038, K(023871, and K(021778…
Philips Medizin Systeme Boblingen GmbH2003—
*K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20
Summary page 2
…(062392, K(061610, K(061052, K(060541, K(060221, K(053522, K(052801, K(051106, K(050762, K(050141, K(042845, K(041235, K(040304, K(033513, K033444, K(032858, K(031481, K(030038, K(023871, and K(021778 Page…
Philips Medizin Systeme Boblingen GmbH2003—
*K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185…
Summary page 2
…(061610, K(061052, K(060541, K(060221, K(053522, K(052801, K(051106, K(050762, K(050141, K(042845, K(041235, K(040304, K(033513, K033444, K(032858, K(031481, K(030038, K(023871, and K(021778 Page 2 of 6 ==…
Philips Medical Systems, Inc.2003—
*K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue Patient…
Summary page 2
…52, K(060541, K(060221, K(053522, K(052801, K(051106, K(050762, K(050141, K(042845, K(041235, K(040304, K(033513, K033444, K(032858, K(031481, K(030038, K(023871, and K(021778 Page 2 of 6 4.…
Philips Medical Systems2002—
*K021778Philips Component Compact Monitor, Release a.04, Model #M1275B
Summary page 2
…K(060221, K(053522, K(052801, K(051106, K(050762, K(050141, K(042845, K(041235, K(040304, K(033513, K033444, K(032858, K(031481, K(030038, K(023871, and K(021778 Page 2 of 6 4. The Philips I…
Philips Medical Systems2002—

Also cleared against K110622: 13 other devices →

What descends from it? (81)

See all 81

10 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH201241
K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201337
K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201337
K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201436
K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH201335
K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH201534
K151681IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH201532
K153156eCareManager 4.0.1Visicu, Inc.20163
K131913Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T…Philips Medizin Systeme Boeblingen GmbH20130
K131829Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20130

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 18 years and passes through 8 companies; a new generation was cleared every 4 months on median.
  • 27 of the 185 ancestors have a recall of any class.
  • Of its descendants, K122439 (Philips Medizin Systeme Boeblingen GmbH, 2012) has gone furthest, with 41 descendants of its own.
  • 13 other devices also cite its predicate K110622.

How does its category compare?

All MHX devices

MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · MHX

8in 2025

2007: 152008: 162009: 132010: 202011: 122012: 162013: 212014: 132015: 142016: 132017: 142018: 112019: 72020: 112021: 52022: 152023: 82024: 52025: 82026 (partial year): 14
2007high 21 (2013) · low 5 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MHX

192in 2025

2007: 96 days median2008: 58 days median2009: 57 days median2010: 90 days median2011: 81 days median2012: 88 days median2013: 120 days median2014: 248 days median2015: 203 days median2016: 149 days median2017: 134 days median2018: 203 days median2019: 243 days median2020: 196 days median2021: 195 days median2022: 189 days median2023: 229 days median2024: 181 days median2025: 192 days median2026 (partial year): 205 days median
2007high 248 (2014) · low 57 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MHX

21so far in 2026, the most since 2007

2007: 32008: 22009: 72010: 132011: 162012: 112013: 142014: 62015: 52016: 72017: 62018: 122019: 62022: 62023: 32024: 32025: 152026 (partial year): 21
2007high 21 (2026) · low 0 (2020)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MHX

3,761in 2025

2007: 1312008: 2322009: 3822010: 9552011: 9492012: 6762013: 1,9972014: 1,6092015: 1,2842016: 1,1052017: 1,1152018: 2,1572019: 1,4622020: 1,7142021: 2,4232022: 1,4702023: 2,2542024: 2,8142025: 3,761
2007high 3,761 (2025) · low 131 (2007)2025

MAUDE reports naming product code MHX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200715963131
200816582232
200913577382
2010209013955
2011128116949
2012168811676
201321120141,997
20141324861,609
20151420351,284
20161314971,105
20171413461,115
201811203122,157
2019724361,462
20201119601,714
2021519502,423
20221518961,470
2023822932,254
2024518132,814
20258192153,761
20261420521—

What is it indicated for?

The monitor is indicated for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients. The monitor is intended to be used for monitoring and recording of, and to generate alarms, for, multiple physiological parameters of adults, pediatrics, and neonates. The monitor is intended for use by trained healthcare professionals in a hospital environment. The monitor is also intended for use during patient…

Read the full statement (1,206 words)

The monitor is indicated for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients.

The monitor is intended to be used for monitoring and recording of, and to generate alarms, for, multiple physiological parameters of adults, pediatrics, and neonates. The monitor is intended for use by trained healthcare professionals in a hospital environment.

The monitor is also intended for use during patient transport inside and outside of the hospital environment.

The monitor is only for use on one patient at a time. It is not intended for home use. Not a therapeutic device. The monitor is for prescription use only.

The EGG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AA±4I EC 11).

ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.

The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.

The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment.

The MPS, MPSSC and MPST monitors are also intended for use during patient transport inside the hospital environment; only the MPS monitor is for use during patient transport outside of the hospital environment. The MIPS, MPSSC and MPST when used with the TRX484WATRX4S5lA IntelliVue Telemetry System Transceiver or with the IntelliVue Cableless measurement Dlevices, are intended for use in a hospital environment and during patient transport inside the hospital environment.

The monitors are only for use on one patient at a time. They are not intended for home use. Not therapeutic devices. The monitors are for prescription use only.

The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AMI EC 11).

ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.

The Predictive Temperature unit is intended for use with adult and pediatric patients in a hospital environment.

The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support tool, is intended for use with adult patients only.

The derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients.

The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.

The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment.

The MP2O/4P30/?4P40/IIPSO monitors are additionally intended for use in transport situations within hospital environments.

The monitors are only for use on one patient at a time. They are not intended for home use. Not therapeutic devices. The monitors are for prescription use only.

The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AMI EC 11).

ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.

The derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients.

The transcutanreous gas measurement (tcGaS) is restricted to neonatal patients only.

HIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of ERG signals. The HIS may be used as an aid in monitoring the effects of certain anesthetic agents.

Use of HIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults, during general anesthesia and sedation.

The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support tool, is intended for use With adult patients only.

The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.

The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment.

The monitors are only for use on one patient at a time. They are not intended for home use. Not therapeutic devices. The monitors are for prescription use only.

The E0G measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AANI EC 11).

ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neoniatal and pediatric patients.

The transcutaneous gas measurement (tccas) is restricted to neonatal patients only.

BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects, of certain anesthetic agents.

Use of BIS monitoring to help guide anesthetic administration my be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support tool, is intended for use with adult patients only.

The derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac, arrhythmia. The PPV measurement has been validated only for adult patients.

The monitor is indicated for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients.

The monitor is intended to be used. for monitoring and recording of, and to generate alarms, for, multiple physiological parameters of adults, pediatrics, and neonates. The monitor is intended for use by trained healthcare professionals in a hospital environment.

The monitor is also intended for use during patient transport inside and outside of the hospital environment.

The monitor is only for use on one patient at a time. It is not intended for home use. Not a therapeutic device. The monitor is for prescription use only.

The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC 11).

ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.

Indications for use as stated in the FDA summary.

Also cleared against K110622

13 other devices cite the same predicate.

  • K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4Philips Medizin Systeme Boeblingen GmbH · 20212 recalls
  • K151681IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 20158 recalls
  • K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2 multi-msrmt-modules for use…Philips Medizin Systeme Boeblingen GmbH · 20151 recall
  • K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient Monitor MX500…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 20141 recall
  • K131913Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T, MP5SCPhilips Medizin Systeme Boeblingen GmbH · 20131 recall
  • K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 20135 recalls

More from Philips Medizin Systeme Boblingen GmbH

12 FDA decisions under this applicant name. See the company

  • K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH · 2015
  • K140535Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizin Systeme Boblingen GmbH · 20145 recalls
  • K102958Philips Avalon Fetal MonitorPhilips Medizin Systeme Boblingen GmbH · 2011
  • K102562Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, & MX800Philips Medizin Systeme Boblingen GmbH · 2010
  • K090360Philips M3001A Multi Measurement ServerPhilips Medizin Systeme Boblingen GmbH · 2009

Recent decisions in MHX

The MHX category page

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  • K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM…GE Healthcare Finland Oy · 2026
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https://510kreport.com/device/K113657 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113657: Intellivue Patient Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113657

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026