510(k) Report

510(k) · Cleared

Recalled · Class II · 2020

Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, and MP90

K083517510(k) SpecialCleared Jan 16, 200951-day reviewClass II21 CFR 870.1025Recalls 2

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

Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · DSI Detector And Alarm, Arrhythmia

Cleared on Jan 16, 2009 as substantially equivalent to K021778 (Philips Medical Systems, 2002) and 22 other predicates after a 51-day review. Its family tree reaches back 26 generations to 1994. 125 later devices descend from it. It has been recalled 2 times.

Decided
Jan 16, 2009
Review
51 days
Class
Class II
Product code
DSI
Recalls
2
Predicates
23

Its longest line of descent runs back 26 generations to K941811 (1994). 172 ancestors in all, the oldest K844187 (1985). 125 later devices descend from it, 18 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2007: 1 other ancestor2006: 4 other ancestors2004: 12 other ancestors2003: 12 other ancestors2005: 2 other ancestors2002: 13 other ancestors2001: 7 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 ancestor2012: 7 descendants cleared2013: 6 descendants cleared2011: 3 descendants cleared2010: 4 descendants cleared2015: 4 descendants cleared2009: 1 descendant cleared2014: 7 descendants cleared2016: 8 descendants cleared2017: 9 descendants cleared2021: 5 descendants cleared2023: 10 descendants cleared2020: 6 descendants cleared2022: 11 descendants cleared2018: 8 descendants cleared2019: 6 descendants cleared2025: 14 descendants cleared2024: 9 descendants cleared2026: 7 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 · 20071990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 29 other ancestors3 generations back: 54 other ancestors4 generations back: 18 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: 18 descendants2 generations forward: 19 descendants3 generations forward: 28 descendants4 generations forward: 20 descendants5 generations forward: 15 descendants6 generations forward: 10 descendants7 generations forward: 9 descendants8 generations forward: 6 descendants K071426 · 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. · 1994−25−20−15−10−50+5
  1. Root · 26 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 22 generations between
  3. 3 generations backK061610 Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  4. 2 generations backK063315 Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH · 2006
  5. 1 generation backK071426 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
  6. This deviceK083517 Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009
  7. Descendant · cites it directly · 124 of its ownK091927 Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009
  8. Descendant · cites it directly · 123 of its ownK100939 Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
  9. Descendant · cites it directly · 103 of its ownK102562 Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30…Philips Medizin Systeme Boblingen GmbH · 2010
  10. Descendant · 2 generations on · 92 of its ownK101449 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
  11. Descendant · cites it directly · 90 of its ownK110622 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · Recalled
Show all 26 generations
  1. Root · 26 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 25 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
  3. 24 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
  4. 23 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
  5. 22 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  6. 21 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
  7. 20 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
  8. 19 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
  9. 18 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
  10. 17 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
  11. 16 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
  12. 15 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
  13. 14 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
  14. 13 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
  15. 12 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
  16. 11 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
  17. 10 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
  18. 9 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
  19. 8 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
  20. 7 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
  21. 6 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  22. 5 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
  23. 4 generations backK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
  24. 3 generations backK061610 Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  25. 2 generations backK063315 Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH · 2006
  26. 1 generation backK071426 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
  27. This deviceK083517 Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009

Showing 5 of 125 descendants. See all descendants

Descendants cleared per year

2009: 12010: 42011: 32012: 72013: 62014: 72015: 42016: 82017: 92018: 82019: 62020: 62021: 52022: 112023: 102024: 92025: 142026: 7
2009high 14 (2025) · low 1 (2009)2026

Most influential descendants

Showing 5 of 125 · See all
  • K091927Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · cites it directly124descendants
  • K100939Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010 · cites it directly123descendants
  • K102562Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boblingen GmbH · 2010 · cites it directly103descendants
  • K101449Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010 · 2 generations on92descendants
  • K110622Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · cites it directly90descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−26K941811HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co.1994—
−25K960934HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co.1996—
−24K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co.1999—
−23K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH1999—
−22K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
−21K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—
−20K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…Philips Medical Systems2002—
−19K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002—
−18K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…Philips Medical Systems2002—
−17K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology…Philips Medical Systems, Inc.2003—
−16K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH2003—
−15K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH2003—
−14K040304Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH2004—
−13K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2004—
−12K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient…Philips Medizin Systeme Boblingen GmbH2004—
−11K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2005—
−10K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizin Systeme Boeblingen GmbH2005—
−9K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2005—
−8K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH2005—
−7K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors…Philips Medizin Systeme Boeblingen GmbH2006—
−6K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2006—
−5K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient…Philips Medizin Systeme Boblingen GmbH20062
−4K061052The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc.2006—
−3K061610Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2006—
−2K063315Intellivue 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—
0 (this device)K083517Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009—
+1K091927Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009—
+1K100939Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010—
+1K102562Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50…Philips Medizin Systeme Boblingen GmbH2010—
+2K101449Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2010—
+1K110622Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20112

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
200170
2002130
2003120
2004120
200520
200640
200710
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201040
201130
201270
201360
201470
201540
201680
201790
201880
201960
202060
202150
2022110
2023100
202490
2025140
202670
FIG. 1 — Lineage of K083517, 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 DSI? 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 DSI device

  1. #1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (23)

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
…ephalogram Signal 3. The modified devices are substantially equivalent to previously cleared Philips IntelliVue Patient Monitors marketed pursuant to 1(021778, 1(030038, 1(032858, 1(033444, 1(033513, 1(040304, 1(040357, 1(041235, K042845, 1(050762, 1(051106, 1(052801, K(05352…
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 IntelliVue Patient Monitors marketed pursuant to 1(021778, 1(030038, 1(032858, 1(033444, 1(033513, 1(040304, 1(040357, 1(041235, K042845, 1(050762, 1(051106, 1(052801, K(053522, K060221…
Philips Medical Systems, Inc.2003—
*K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O.
Summary page 2
…3. The modified devices are substantially equivalent to previously cleared Philips IntelliVue Patient Monitors marketed pursuant to 1(021778, 1(030038, 1(032858, 1(033444, 1(033513, 1(040304, 1(040357, 1(041235, K042845, 1(050762, 1(051106, 1(052801, K(053522, K060221, K060541,…
Philips Medizin Systeme Boblingen GmbH2003—
*K033444Philips Medical Systems, M3012A- Hemodynamic Extension to the Multi-Measurement Server
Summary page 2
…modified devices are substantially equivalent to previously cleared Philips IntelliVue Patient Monitors marketed pursuant to 1(021778, 1(030038, 1(032858, 1(033444, 1(033513, 1(040304, 1(040357, 1(041235, K042845, 1(050762, 1(051106, 1(052801, K(053522, K060221, K060541, K(061052,…
Philips Medical Systems2003—
*K033513Easi Ecg Algorithm
Summary page 2
…s are substantially equivalent to previously cleared Philips IntelliVue Patient Monitors marketed pursuant to 1(021778, 1(030038, 1(032858, 1(033444, 1(033513, 1(040304, 1(040357, 1(041235, K042845, 1(050762, 1(051106, 1(052801, K(053522, K060221, K060541, K(061052, 1(061610, 1(062…
Philips Medical Systems2004—
*K040304Philips Intellivue Patient Monitor, Models MP40 & MP50
Summary page 2
…tantially equivalent to previously cleared Philips IntelliVue Patient Monitors marketed pursuant to 1(021778, 1(030038, 1(032858, 1(033444, 1(033513, 1(040304, 1(040357, 1(041235, K042845, 1(050762, 1(051106, 1(052801, K(053522, K060221, K060541, K(061052, 1(061610, 1(062283,…
Philips Medizin Systeme Boeblingen GmbH2004—
*K040357M3290A Intellivue Information Center Software Release F.O and the M4840A Telemetry…
Summary page 2
…equivalent to previously cleared Philips IntelliVue Patient Monitors marketed pursuant to 1(021778, 1(030038, 1(032858, 1(033444, 1(033513, 1(040304, 1(040357, 1(041235, K042845, 1(050762, 1(051106, 1(052801, K(053522, K060221, K060541, K(061052, 1(061610, 1(062283, 1(063315,…
Philips Medical Systems, Inc.2004—
*K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors
Summary page 2
…to previously cleared Philips IntelliVue Patient Monitors marketed pursuant to 1(021778, 1(030038, 1(032858, 1(033444, 1(033513, 1(040304, 1(040357, 1(041235, K042845, 1(050762, 1(051106, 1(052801, K(053522, K060221, K060541, K(061052, 1(061610, 1(062283, 1(063315, 1(062392,…
Philips Medizin Systeme Boeblingen GmbH2004—
*K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient Monitors
Summary page 2
…previously cleared Philips IntelliVue Patient Monitors marketed pursuant to 1(021778, 1(030038, 1(032858, 1(033444, 1(033513, 1(040304, 1(040357, 1(041235, K042845, 1(050762, 1(051106, 1(052801, K(053522, K060221, K060541, K(061052, 1(061610, 1(062283, 1(063315, 1(062392, 1(063725…
Philips Medizin Systeme Boblingen GmbH2004—
*K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90
Summary page 2
…y cleared Philips IntelliVue Patient Monitors marketed pursuant to 1(021778, 1(030038, 1(032858, 1(033444, 1(033513, 1(040304, 1(040357, 1(041235, K042845, 1(050762, 1(051106, 1(052801, K(053522, K060221, K060541, K(061052, 1(061610, 1(062283, 1(063315, 1(062392, 1(063725, 1(071426…
Philips Medizin Systeme Boeblingen GmbH2005—
*K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors
Summary page 2
…Philips IntelliVue Patient Monitors marketed pursuant to 1(021778, 1(030038, 1(032858, 1(033444, 1(033513, 1(040304, 1(040357, 1(041235, K042845, 1(050762, 1(051106, 1(052801, K(053522, K060221, K060541, K(061052, 1(061610, 1(062283, 1(063315, 1(062392, 1(063725, 1(071426, 1(082633…
Philips Medizin Systeme Boeblingen GmbH2005—
*K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50, MP60…
Summary page 2
…ue Patient Monitors marketed pursuant to 1(021778, 1(030038, 1(032858, 1(033444, 1(033513, 1(040304, 1(040357, 1(041235, K042845, 1(050762, 1(051106, 1(052801, K(053522, K060221, K060541, K(061052, 1(061610, 1(062283, 1(063315, 1(062392, 1(063725, 1(071426, 1(082633.…
Philips Medizin Systeme Boeblingen GmbH2005—
*K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00
Summary page 2
…Monitors marketed pursuant to 1(021778, 1(030038, 1(032858, 1(033444, 1(033513, 1(040304, 1(040357, 1(041235, K042845, 1(050762, 1(051106, 1(052801, K(053522, K060221, K060541, K(061052, 1(061610, 1(062283, 1(063315, 1(062392, 1(063725, 1(071426, 1(082633.…
Philips Medizin Systeme Boeblingen GmbH2006—
*K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient…
Summary page 2
…s marketed pursuant to 1(021778, 1(030038, 1(032858, 1(033444, 1(033513, 1(040304, 1(040357, 1(041235, K042845, 1(050762, 1(051106, 1(052801, K(053522, K060221, K060541, K(061052, 1(061610, 1(062283, 1(063315, 1(062392, 1(063725, 1(071426, 1(082633.…
Philips Medizin Systeme Boeblingen GmbH2006—
*K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient Monitors
Summary page 2
…arketed pursuant to 1(021778, 1(030038, 1(032858, 1(033444, 1(033513, 1(040304, 1(040357, 1(041235, K042845, 1(050762, 1(051106, 1(052801, K(053522, K060221, K060541, K(061052, 1(061610, 1(062283, 1(063315, 1(062392, 1(063725, 1(071426, 1(082633.…
Philips Medizin Systeme Boblingen GmbH20062
*K061052The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90
Summary page 2
…suant to 1(021778, 1(030038, 1(032858, 1(033444, 1(033513, 1(040304, 1(040357, 1(041235, K042845, 1(050762, 1(051106, 1(052801, K(053522, K060221, K060541, K(061052, 1(061610, 1(062283, 1(063315, 1(062392, 1(063725, 1(071426, 1(082633.…
Philips Medical Systems North America, Inc.2006—
*K061610Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…
Summary page 2
…(021778, 1(030038, 1(032858, 1(033444, 1(033513, 1(040304, 1(040357, 1(041235, K042845, 1(050762, 1(051106, 1(052801, K(053522, K060221, K060541, K(061052, 1(061610, 1(062283, 1(063315, 1(062392, 1(063725, 1(071426, 1(082633.…
Philips Medizin Systeme Boeblingen GmbH2006—
*K062283The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient Monitors
Summary page 2
…(030038, 1(032858, 1(033444, 1(033513, 1(040304, 1(040357, 1(041235, K042845, 1(050762, 1(051106, 1(052801, K(053522, K060221, K060541, K(061052, 1(061610, 1(062283, 1(063315, 1(062392, 1(063725, 1(071426, 1(082633. to 4…
Philips Medical Systems North America, Inc.2006—
*K063315Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90
Summary page 2
…8, 1(033444, 1(033513, 1(040304, 1(040357, 1(041235, K042845, 1(050762, 1(051106, 1(052801, K(053522, K060221, K060541, K(061052, 1(061610, 1(062283, 1(063315, 1(062392, 1(063725, 1(071426, 1(082633. to 4. The modificati…
Philips Medizin Systeme Boeblingen GmbH2006—
*K062392Philips MP5 Intellivue Patient Monitor
Summary page 2
…4, 1(033513, 1(040304, 1(040357, 1(041235, K042845, 1(050762, 1(051106, 1(052801, K(053522, K060221, K060541, K(061052, 1(061610, 1(062283, 1(063315, 1(062392, 1(063725, 1(071426, 1(082633. to 4. The modification is a ch…
Philips Medizin Systeme Boeblingen GmbH2006—
*K063725MP5 Intellivue Patient Monitor
Summary page 2
…(033513, 1(040304, 1(040357, 1(041235, K042845, 1(050762, 1(051106, 1(052801, K(053522, K060221, K060541, K(061052, 1(061610, 1(062283, 1(063315, 1(062392, 1(063725, 1(071426, 1(082633. to 4. The modification is a change of th…
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007—
*K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient…
Summary page 2
…(040304, 1(040357, 1(041235, K042845, 1(050762, 1(051106, 1(052801, K(053522, K060221, K060541, K(061052, 1(061610, 1(062283, 1(063315, 1(062392, 1(063725, 1(071426, 1(082633. to 4. The modification is a change of the labellin…
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007—
*K082633Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50…
Summary page 2
…(040357, 1(041235, K042845, 1(050762, 1(051106, 1(052801, K(053522, K060221, K060541, K(061052, 1(061610, 1(062283, 1(063315, 1(062392, 1(063725, 1(071426, 1(082633. to 4. The modification is a change of the labelling with reg…
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20083

Also cleared against K021778: 30 other devices →

What descends from it? (125)

See all 125

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

NumberDeviceApplicantDecidedDescendants
K091927Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009124
K100939Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010123
K102562Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boblingen GmbH2010103
K110622Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201190
K110474Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201184
K113657Intellivue Patient MonitorPhilips Medizin Systeme Boblingen GmbH201281
K113441Physiological Monitor, Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201278
K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201246
K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH201241
K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201337

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 18, 2020Class IIZ-0545-2021Process controlSpeakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP or by the absence of audible sound, may result in delayed treatment of the patient.
Aug 31, 2010Not classifiedZ-2626-2010Process designSpeakers on the Philips IntelliVue X2 and MP2 patient monitors may fail, causing absence of an audible alarm and delaying patient treatment.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 15 years and passes through 8 companies; a new generation was cleared every 3 months on median.
  • 21 of the 172 ancestors have a recall of any class.
  • Of its descendants, K091927 (Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, 2009) has gone furthest, with 124 descendants of its own.
  • 30 other devices also cite its predicate K021778.

How does its category compare?

All DSI devices

DSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · DSI

1in 2025

2007: 72008: 52009: 62010: 62011: 62012: 32013: 12014: 42015: 92016: 62018: 22019: 32020: 22023: 22024: 12025: 12026 (partial year): 1
2007high 9 (2015) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSI

243in 2019

2007: 151 days median2008: 70 days median2009: 73 days median2010: 111 days median2011: 114 days median2012: 113 days median2014: 200 days median2015: 127 days median2016: 224 days median2019: 243 days median
2007high 243 (2019) · low 70 (2008)2026

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

Recalls per year · DSI

18in 2025

2007: 42008: 82009: 32010: 52011: 32012: 12018: 12019: 42020: 22022: 12023: 22025: 182026 (partial year): 1
2007high 18 (2025) · low 0 (2013)2026

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

Adverse event reports per year · DSI

712in 2025

2007: 642008: 1562009: 2792010: 8232011: 7932012: 7662013: 7952014: 1,0002015: 1,6452016: 4,3522017: 3,5942018: 3,6482019: 3,4852020: 3,0842021: 3,0922022: 1,6382023: 1,6162024: 1,3202025: 712
2007high 4,352 (2016) · low 64 (2007)2025

MAUDE reports naming product code DSI, 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
20077151464
20085708156
20096733279
201061115823
201161143793
201231131766
20131—0795
2014420001,000
2015912701,645
2016622404,352
20170—03,594
20182—13,648
2019324343,485
20202—23,084
20210—03,092
20220—11,638
20232—21,616
20241—01,320
20251—18712
20261—1—

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 and recording of and to generate alarms for multiple physiological parameters of adults, pediatrics and neonates in hospital environments

Indications for use as stated in the FDA summary.

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 Medizinsysteme Boeblingen…

25 FDA decisions under this applicant name. See the company

  • K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient Monitor MX500…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 20141 recall
  • K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2014
  • K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 20135 recalls
  • K131829Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2013
  • K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 20138 recalls

Recent decisions in DSI

The DSI category page

  • K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc. · 2026
  • K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc. · 2025
  • K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc. · 2024
  • K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc. · 2023
  • K231276SmartCardia 7L PlatformSmartcardia SA · 2023

https://510kreport.com/device/K083517 · printed Nov 4, 2026

Cite this page

510(k) Report. “K083517: Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, and MP90.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083517

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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