510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient Monitor MX500, Intellivue Patient

K141015510(k) SpecialCleared May 19, 201428-day reviewClass II21 CFR 870.1025Recalls 1

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 · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on May 19, 2014 as substantially equivalent to K130849 (Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, 2013) and 10 other predicates after a 28-day review. Its family tree reaches back 34 generations to 1994. 1 of the 268 devices in its family, counting itself, has a Class I recall. 36 later devices descend from it. It has been recalled once.

Decided
May 19, 2014
Review
28 days
Class
Class II
Product code
MHX
Recalls
1
Predicates
11

Its longest line of descent runs back 34 generations to K941811 (1994). 231 ancestors in all, the oldest K844187 (1985). 36 later devices descend from it, 2 citing it directly. 1 of the 268 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2013: 1 other ancestor2012: 2 other ancestors2011: 1 other ancestor2010: 3 other ancestors2009: 3 other ancestors2008: 3 other ancestors2007: 4 other ancestors2006: 7 other ancestors2005: 6 other ancestors2004: 16 other ancestors2003: 13 other ancestors2002: 16 other ancestors2001: 9 other ancestors2000: 20 other ancestors1999: 12 other ancestors1998: 17 other ancestors1997: 9 other ancestors, 1 with a Class I recall11996: 10 other ancestors1995: 9 other ancestors1993: 6 other ancestors1992: 7 other ancestors1990: 7 other ancestors1989: 3 other ancestors1986: 1 other ancestor1994: 2 other ancestors1991: 8 other ancestors1987: 1 other ancestor1985: 1 other ancestor2015: 2 descendants cleared2016: 2 descendants cleared2018: 4 descendants cleared2017: 2 descendants cleared2019: 4 descendants cleared2020: 1 descendant cleared2021: 1 descendant cleared2022: 3 descendants cleared2023: 6 descendants cleared2026: 4 descendants cleared2025: 6 descendants cleared2024: 1 descendant 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 · recalledK113657 · Intellivue Patient Monitor · Philips Medizin Systeme Boblingen GmbH · 2012K122439 · Intellivue Patient Monitor · Philips Medizin Systeme Boeblingen GmbH · 2012 · recalledK130849 · Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2013 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 18 other ancestors3 generations back: 54 other ancestors4 generations back: 46 other ancestors5 generations back: 20 other ancestors6 generations back: 21 other ancestors7 generations back: 17 other ancestors, 1 with a Class I recall18 generations back: 13 other ancestors9 generations back: 3 other ancestors 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 12 descendants4 generations forward: 7 descendants5 generations forward: 7 descendants6 generations forward: 3 descendants7 generations forward: 3 descendants K130849 · Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2013 · recalledK122439 · Intellivue Patient Monitor · Philips Medizin Systeme Boeblingen GmbH · 2012 · recalledK113657 · Intellivue Patient Monitor · Philips Medizin Systeme Boblingen GmbH · 2012K110622 · 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. · 1994−30−20−100
  1. Root · 34 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 30 generations between
  3. 3 generations backK113657 Intellivue Patient MonitorPhilips Medizin Systeme Boblingen GmbH · 2012
  4. 2 generations backK122439 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2012 · Recalled
  5. 1 generation backK130849 Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2013 · Recalled
  6. This deviceK141015 Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2014
  7. Descendant · cites it directly · 34 of its ownK150975 Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue…Philips Medizin Systeme Boeblingen GmbH · 2015 · Recalled
  8. Descendant · cites it directly · 32 of its ownK151681 IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2015 · Recalled
  9. Descendant · 2 generations on · 31 of its ownK161531 IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and…Philips Medizin Systeme Boeblingen GmbH · 2016 · Recalled
  10. Descendant · 3 generations on · 8 of its ownK171801 IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3…Philips Medizin Systeme Boeblingen GmbH · 2017 · Recalled
  11. Descendant · 3 generations on · 6 of its ownK221704 HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP)…Edwards Lifesciences, LLC · 2022
Show all 34 generations
  1. Root · 34 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 33 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
  3. 32 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
  4. 31 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
  5. 30 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  6. 29 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
  7. 28 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
  8. 27 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
  9. 26 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
  10. 25 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
  11. 24 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
  12. 23 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
  13. 22 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
  14. 21 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
  15. 20 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
  16. 19 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
  17. 18 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
  18. 17 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
  19. 16 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
  20. 15 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
  21. 14 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  22. 13 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
  23. 12 generations backK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
  24. 11 generations backK061610 Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  25. 10 generations backK063315 Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH · 2006
  26. 9 generations backK071426 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
  27. 8 generations backK083517 Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · Recalled
  28. 7 generations backK091927 Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009
  29. 6 generations backK100939 Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
  30. 5 generations backK101449 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
  31. 4 generations backK110622 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · Recalled
  32. 3 generations backK113657 Intellivue Patient MonitorPhilips Medizin Systeme Boblingen GmbH · 2012
  33. 2 generations backK122439 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2012 · Recalled
  34. 1 generation backK130849 Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2013 · Recalled
  35. This deviceK141015 Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2014

Showing 5 of 36 descendants. See all descendants

Descendants cleared per year

2015: 22016: 22017: 22018: 42019: 42020: 12021: 12022: 32023: 62024: 12025: 62026: 4
2015high 6 (2023) · low 1 (2020)2026

Class I recalls in this family

  • K970209 Capnocheck Plus7 generations back · 1997

Most influential descendants

Showing 5 of 36 · See all
  • K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH · 2015 · cites it directly34descendants
  • K151681IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2015 · cites it directly32descendants
  • K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH · 2016 · 2 generations on31descendants
  • K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH · 2017 · 3 generations on8descendants
  • K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC · 2022 · 3 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−34K941811HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co.1994—
−33K960934HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co.1996—
−32K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co.1999—
−31K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH1999—
−30K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
−29K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—
−28K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…Philips Medical Systems2002—
−27K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002—
−26K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…Philips Medical Systems2002—
−25K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology…Philips Medical Systems, Inc.2003—
−24K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH2003—
−23K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH2003—
−22K040304Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH2004—
−21K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2004—
−20K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient…Philips Medizin Systeme Boblingen GmbH2004—
−19K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2005—
−18K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizin Systeme Boeblingen GmbH2005—
−17K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2005—
−16K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH2005—
−15K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors…Philips Medizin Systeme Boeblingen GmbH2006—
−14K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2006—
−13K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient…Philips Medizin Systeme Boblingen GmbH20062
−12K061052The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc.2006—
−11K061610Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2006—
−10K063315Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80…Philips Medizin Systeme Boeblingen GmbH2006—
−9K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007—
−8K083517Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20092
−7K091927Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009—
−6K100939Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010—
−5K101449Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2010—
−4K110622Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20112
−3K113657Intellivue Patient MonitorPhilips Medizin Systeme Boblingen GmbH2012—
−2K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH20124
−1K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20138
0 (this device)K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2014—
+1K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH20151
+1K151681IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH20158
+2K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement…Philips Medizin Systeme Boeblingen GmbH20161
+3K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue…Philips Medizin Systeme Boeblingen GmbH20174
+3K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global…Edwards Lifesciences, LLC2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
198610
198710
198930
199070
199180
199270
199360
199420
199590
1996100
199791
1998170
1999120
2000200
200190
2002160
2003130
2004160
200560
200670
200740
200830
200930
201030
201110
201220
201310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201520
201620
201720
201840
201940
202010
202110
202230
202360
202410
202560
202640
FIG. 1 — Lineage of K141015, 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.

1 device in this family has a Class I recall. 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? (11)

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
*K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450
Summary page 2
…quivalent to the previously cleared IntelliVue Patient Monitors MX400, MX450, M7X500, and MX5O0 software Rev. K.10 marketed pursuant to K130849 and K131 872 and the IntelliVue Patient Monitor MX800 marketed pursuant to K122439, K(120366, KI 13441, KI 13657…
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20138
*K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550
Summary page 2
…the previously cleared IntelliVue Patient Monitors MX400, MX450, M7X500, and MX5O0 software Rev. K.10 marketed pursuant to K130849 and K131 872 and the IntelliVue Patient Monitor MX800 marketed pursuant to K122439, K(120366, KI 13441, KI 13657,1(1 10474, K…
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20135
*K122439Intellivue Patient Monitor
Summary page 2
…0, and MX5O0 software Rev. K.10 marketed pursuant to K130849 and K131 872 and the IntelliVue Patient Monitor MX800 marketed pursuant to K122439, K(120366, KI 13441, KI 13657,1(1 10474, KI 10622, K(102562, K101449, and K(100939.…
Philips Medizin Systeme Boeblingen GmbH20124
*K120366Intellivue Patient Monitor
Summary page 2
…0 software Rev. K.10 marketed pursuant to K130849 and K131 872 and the IntelliVue Patient Monitor MX800 marketed pursuant to K122439, K(120366, KI 13441, KI 13657,1(1 10474, KI 10622, K(102562, K101449, and K(100939. i Page…
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2012—
*K113441Physiological Monitor, Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20121
*K113657Intellivue Patient MonitorPhilips Medizin Systeme Boblingen GmbH2012—
*K110474Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20111
*K110622Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20112
*K102562Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60…
Summary page 2
…and K131 872 and the IntelliVue Patient Monitor MX800 marketed pursuant to K122439, K(120366, KI 13441, KI 13657,1(1 10474, KI 10622, K(102562, K101449, and K(100939. i Page 2 of 5…
Philips Medizin Systeme Boblingen GmbH2010—
*K101449Intellivue Patient Monitor
Summary page 2
…872 and the IntelliVue Patient Monitor MX800 marketed pursuant to K122439, K(120366, KI 13441, KI 13657,1(1 10474, KI 10622, K(102562, K101449, and K(100939. i Page 2 of 5…
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010—
*K100939Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70…
Summary page 2
…telliVue Patient Monitor MX800 marketed pursuant to K122439, K(120366, KI 13441, KI 13657,1(1 10474, KI 10622, K(102562, K101449, and K(100939. i Page 2 of 5 K141015…
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010—

Also cleared against K130849: 2 other devices →

What descends from it? (36)

See all 36

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

NumberDeviceApplicantDecidedDescendants
K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH201534
K151681IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH201532

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 26, 2016Class IIZ-2328-2016Nonconforming Material/ComponentIf an affected Patient Monitor has been powered on continuously for several months, any displayed waveforms will contain outdated data and therefore fail to reflect the patients current condition.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K970209Capnocheck PlusBci Intl., Inc. · 1997 · 7 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 20 years and passes through 8 companies; a new generation was cleared every 4 months on median.
  • 39 of the 231 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K150975 (Philips Medizin Systeme Boeblingen GmbH, 2015) has gone furthest, with 34 descendants of its own.
  • 2 other devices also cite its predicate K130849.

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. 2014, 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 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 additionally intended for use…

Read the full statement (292 words)

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 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 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.

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

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

The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.

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 IntelliVue NMT Module is intended to be used as an objective neuromuscular transmission monitor, using accelerometry for measuring the muscle contraction following an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients.

Indications for use as stated in the FDA summary.

Also cleared against K130849

2 other devices cite the same predicate.

  • 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

More from Philips Medizinsysteme Boeblingen…

25 FDA decisions under this applicant name. See the company

  • 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
  • K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2012

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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  • K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc. · 2026

https://510kreport.com/device/K141015 · printed Nov 3, 2026

Cite this page

510(k) Report. “K141015: Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient Monitor MX500, Intellivue Patient.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K141015

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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