510(k) Report

510(k) · Cleared

Cleared

Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors

K061610510(k) SpecialCleared Aug 14, 200666-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 Boeblingen GmbH · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Aug 14, 2006 as substantially equivalent to K021778 (Philips Medical Systems, 2002) and 14 other predicates after a 66-day review. Its family tree reaches back 23 generations to 1994. 155 later devices descend from it.

Decided
Aug 14, 2006
Review
66 days
Class
Class II
Product code
MHX
Recalls
None
Predicates
15

Its longest line of descent runs back 23 generations to K941811 (1994). 150 ancestors in all, the oldest K844187 (1985). 155 later devices descend from it, 16 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 11 other ancestors2006: 2 other ancestors2003: 8 other ancestors2002: 11 other ancestors2000: 19 other ancestors1999: 9 other ancestors1998: 13 other ancestors1997: 7 other ancestors1996: 8 other ancestors1992: 6 other ancestors2005: 1 other ancestor2001: 5 other ancestors1995: 5 other ancestors1994: 2 other ancestors1993: 5 other ancestors1991: 6 other ancestors1990: 5 other ancestors1989: 2 other ancestors1987: 1 other ancestor1985: 1 other ancestor2007: 2 descendants cleared2012: 8 descendants cleared2013: 9 descendants cleared2009: 5 descendants cleared2011: 6 descendants cleared2006: 1 descendant cleared2015: 6 descendants cleared2008: 2 descendants cleared2010: 4 descendants cleared2014: 9 descendants cleared2016: 9 descendants cleared2017: 9 descendants cleared2021: 6 descendants cleared2023: 11 descendants cleared2020: 6 descendants cleared2022: 13 descendants cleared2018: 10 descendants cleared2019: 6 descendants cleared2025: 15 descendants cleared2026: 7 descendants cleared2024: 11 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) ×9: 9 generations cleared close together, K042845 (2004), K050141 (2005), K050762 (2005), K051106 (2005), K052801 (2005), K053522 (2006), K060221 (2006), K060541 (2006), K061052 (2006) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 21 other ancestors3 generations back: 44 other ancestors4 generations back: 26 other ancestors5 generations back: 14 other ancestors6 generations back: 12 other ancestors7 generations back: 8 other ancestors8 generations back: 1 other ancestor 1 generation forward: 16 descendants2 generations forward: 21 descendants3 generations forward: 31 descendants4 generations forward: 28 descendants5 generations forward: 23 descendants6 generations forward: 12 descendants7 generations forward: 11 descendants8 generations forward: 7 descendants9 generations forward: 6 descendants K061052 · 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. · 1994−20−15−10−50+5
  1. Root · 23 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 19 generations between
  3. 3 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  4. 2 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
  5. 1 generation backK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
  6. This deviceK061610 Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  7. Descendant · cites it directly · 154 of its ownK063315 Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH · 2006
  8. Descendant · cites it directly · 151 of its ownK071426 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
  9. Descendant · cites it directly · 127 of its ownK082633 Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2008 · Recalled
  10. Descendant · cites it directly · 125 of its ownK083517 Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · Recalled
  11. Descendant · cites it directly · 124 of its ownK091927 Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009
Show all 23 generations
  1. Root · 23 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 22 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
  3. 21 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
  4. 20 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
  5. 19 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  6. 18 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
  7. 17 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
  8. 16 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
  9. 15 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
  10. 14 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
  11. 13 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
  12. 12 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
  13. 11 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
  14. 10 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
  15. 9 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
  16. 8 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
  17. 7 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
  18. 6 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
  19. 5 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
  20. 4 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
  21. 3 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  22. 2 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
  23. 1 generation backK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
  24. This deviceK061610 Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006

Showing 5 of 155 descendants. See all descendants

Descendants cleared per year

2006: 12007: 22008: 22009: 52010: 42011: 62012: 82013: 92014: 92015: 62016: 92017: 92018: 102019: 62020: 62021: 62022: 132023: 112024: 112025: 152026: 7
2006high 15 (2025) · low 1 (2006)2026

Most influential descendants

Showing 5 of 155 · See all
  • K063315Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90Philips Medizin Systeme Boeblingen GmbH · 2006 · cites it directly154descendants
  • K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007 · cites it directly151descendants
  • K082633Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2008 · cites it directly127descendants
  • K083517Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · cites it directly125descendants
  • K091927Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · cites it directly124descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−23K941811HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co.1994—
−22K960934HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co.1996—
−21K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co.1999—
−20K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH1999—
−19K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
−18K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—
−17K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…Philips Medical Systems2002—
−16K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002—
−15K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…Philips Medical Systems2002—
−14K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology…Philips Medical Systems, Inc.2003—
−13K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH2003—
−12K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH2003—
−11K040304Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH2004—
−10K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2004—
−9K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient…Philips Medizin Systeme Boblingen GmbH2004—
−8K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2005—
−7K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizin Systeme Boeblingen GmbH2005—
−6K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2005—
−5K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH2005—
−4K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors…Philips Medizin Systeme Boeblingen GmbH2006—
−3K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2006—
−2K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient…Philips Medizin Systeme Boblingen GmbH20062
−1K061052The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc.2006—
0 (this device)K061610Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2006—
+1K063315Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80…Philips Medizin Systeme Boeblingen GmbH2006—
+1K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007—
+1K082633Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20083
+1K083517Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20092
+1K091927Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
198710
198920
199050
199160
199260
199350
199420
199550
199680
199770
1998130
199990
2000190
200150
2002110
200380
2004110
200510
200620

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200720
200820
200950
201040
201160
201280
201390
201490
201560
201690
201790
2018100
201960
202060
202160
2022130
2023110
2024110
2025150
202670
FIG. 1 — Lineage of K061610, 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? (15)

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
*K021778Philips Component Compact Monitor, Release a.04, Model #M1275B
Summary page 2
…am Signal 3. The modified devices are substantially equivalent to previously cleared Philips devices marketed pursuant to, 1(021778, 1(030038, 1(032858, 1(033513, 1(040304, K041235, 1(042845, 1(050141, 050762, K(051106, K0…
Philips Medical Systems2002—
*K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185…
Summary page 2
…Signal 3. The modified devices are substantially equivalent to previously cleared Philips devices marketed pursuant to, 1(021778, 1(030038, 1(032858, 1(033513, 1(040304, K041235, 1(042845, 1(050141, 050762, K(051106, K052801,…
Philips Medical Systems, Inc.2003—
*K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O.
Summary page 2
…Signal 3. The modified devices are substantially equivalent to previously cleared Philips devices marketed pursuant to, 1(021778, 1(030038, 1(032858, 1(033513, 1(040304, K041235, 1(042845, 1(050141, 050762, K(051106, K052801,…
Philips Medizin Systeme Boblingen GmbH2003—
*K033513Easi Ecg Algorithm
Summary page 2
…ied devices are substantially equivalent to previously cleared Philips devices marketed pursuant to, 1(021778, 1(030038, 1(032858, 1(033513, 1(040304, K041235, 1(042845, 1(050141, 050762, K(051106, K052801, 1(053522, 1(0602…
Philips Medical Systems2004—
*K040304Philips Intellivue Patient Monitor, Models MP40 & MP50
Summary page 2
…are substantially equivalent to previously cleared Philips devices marketed pursuant to, 1(021778, 1(030038, 1(032858, 1(033513, 1(040304, K041235, 1(042845, 1(050141, 050762, K(051106, K052801, 1(053522, 1(060221, 1(0…
Philips Medizin Systeme Boeblingen GmbH2004—
*K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors
Summary page 2
…tially equivalent to previously cleared Philips devices marketed pursuant to, 1(021778, 1(030038, 1(032858, 1(033513, 1(040304, K041235, 1(042845, 1(050141, 050762, K(051106, K052801, 1(053522, 1(060221, 1(060541 and K(…
Philips Medizin Systeme Boeblingen GmbH2004—
*K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient Monitors
Summary page 2
…t to previously cleared Philips devices marketed pursuant to, 1(021778, 1(030038, 1(032858, 1(033513, 1(040304, K041235, 1(042845, 1(050141, 050762, K(051106, K052801, 1(053522, 1(060221, 1(060541 and K(061052 4 .The…
Philips Medizin Systeme Boblingen GmbH2004—
*K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient Monitors
Summary page 2
…eviously cleared Philips devices marketed pursuant to, 1(021778, 1(030038, 1(032858, 1(033513, 1(040304, K041235, 1(042845, 1(050141, 050762, K(051106, K052801, 1(053522, 1(060221, 1(060541 and K(061052 4 .The modifica…
Philips Medizin Systeme Boeblingen GmbH2005—
*K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90
Summary page 2
…cleared Philips devices marketed pursuant to, 1(021778, 1(030038, 1(032858, 1(033513, 1(040304, K041235, 1(042845, 1(050141, 050762, K(051106, K052801, 1(053522, 1(060221, 1(060541 and K(061052 4 .The modification is…
Philips Medizin Systeme Boeblingen GmbH2005—
*K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors
Summary page 2
…hilips devices marketed pursuant to, 1(021778, 1(030038, 1(032858, 1(033513, 1(040304, K041235, 1(042845, 1(050141, 050762, K(051106, K052801, 1(053522, 1(060221, 1(060541 and K(061052 4 .The modification is the introd…
Philips Medizin Systeme Boeblingen GmbH2005—
*K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50, MP60…
Summary page 2
…evices marketed pursuant to, 1(021778, 1(030038, 1(032858, 1(033513, 1(040304, K041235, 1(042845, 1(050141, 050762, K(051106, K052801, 1(053522, 1(060221, 1(060541 and K(061052 4 .The modification is the introduction of…
Philips Medizin Systeme Boeblingen GmbH2005—
*K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00
Summary page 2
…1(030038, 1(032858, 1(033513, 1(040304, K041235, 1(042845, 1(050141, 050762, K(051106, K052801, 1(053522, 1(060221, 1(060541 and K(061052 4 .The modification is the introduction of Release D.0S software for the IntelliVue…
Philips Medizin Systeme Boeblingen GmbH2006—
*K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient…
Summary page 2
…1(032858, 1(033513, 1(040304, K041235, 1(042845, 1(050141, 050762, K(051106, K052801, 1(053522, 1(060221, 1(060541 and K(061052 4 .The modification is the introduction of Release D.0S software for the IntelliVue patient m…
Philips Medizin Systeme Boeblingen GmbH2006—
*K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient Monitors
Summary page 2
…032858, 1(033513, 1(040304, K041235, 1(042845, 1(050141, 050762, K(051106, K052801, 1(053522, 1(060221, 1(060541 and K(061052 4 .The modification is the introduction of Release D.0S software for the IntelliVue patient monitor devices.…
Philips Medizin Systeme Boblingen GmbH20062
*K061052The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90
Summary page 2
…1(033513, 1(040304, K041235, 1(042845, 1(050141, 050762, K(051106, K052801, 1(053522, 1(060221, 1(060541 and K(061052 4 .The modification is the introduction of Release D.0S software for the IntelliVue patient monitor devices. 5. The mo…
Philips Medical Systems North America, Inc.2006—

Also cleared against K021778: 30 other devices →

What descends from it? (155)

See all 155

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

NumberDeviceApplicantDecidedDescendants
K063315Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90Philips Medizin Systeme Boeblingen GmbH2006154
K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007151
K082633Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2008127
K083517Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009125
K091927Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009124
K102562Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boblingen GmbH2010103
K082583Intellivue Patient Monitor, Intellibridge Module, Models MP40, MP50, MP60, MP70, MP80…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN200994
K110622Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201190
K113657Intellivue Patient MonitorPhilips Medizin Systeme Boblingen GmbH201281
K113441Physiological Monitor, Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201278

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 12 years and passes through 7 companies; a new generation was cleared every 3 months on median.
  • 15 of the 150 ancestors have a recall of any class.
  • Of its descendants, K063315 (Philips Medizin Systeme Boeblingen GmbH, 2006) has gone furthest, with 154 descendants of its own.
  • 30 other devices also cite its predicate K021778.

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.

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?

Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare facilities. The MP20, MP30, MP40 and MP50 are additionally intended for use in transport situations within healthcare facilities.

ST Segment monitoring is restricted to adult patients only.

The transcutaneous gas measurement (tcpO2 / tcpCO2) is restricted to neonatal patients only.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K021778

30 other devices cite the same predicate.

  • K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 20124 recalls
  • K113657Intellivue Patient MonitorPhilips Medizin Systeme Boblingen GmbH · 2012
  • K113441Physiological Monitor, Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 20121 recall
  • K110622Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 20112 recalls
  • K102562Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, & MX800Philips Medizin Systeme Boblingen GmbH · 2010
  • K101449Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010

More from Philips Medizin Systeme Boeblingen GmbH

48 FDA decisions under this applicant name. See the company

  • K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX…Philips Medizin Systeme Boeblingen GmbH · 2026
  • K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH · 2025
  • K233440Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)Philips Medizin Systeme Boeblingen GmbH · 2024
  • K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH · 2023
  • K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH · 2023

Recent decisions in MHX

The MHX category page

  • K260676Radius VSM and AccessoriesMasimo Corporation · 2026
  • K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM…GE Healthcare Finland Oy · 2026
  • K260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland Oy · 2026
  • K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc. · 2026
  • K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc. · 2026

https://510kreport.com/device/K061610 · printed Nov 5, 2026

Cite this page

510(k) Report. “K061610: Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061610

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Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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