510(k) Report

510(k) · Cleared

Recalled · Class II · 2025

Patient Monitor

K113623510(k) TraditionalCleared Feb 1, 201258-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

Edan Instruments, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Feb 1, 2012 as substantially equivalent to K100939 (Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, 2010) and 5 other predicates after a 58-day review. Its family tree reaches back 29 generations to 1994. 1 of the 239 devices in its family, counting itself, has a Class I recall. 15 later devices descend from it. It has been recalled 2 times.

Decided
Feb 1, 2012
Review
58 days
Class
Class II
Product code
MHX
Recalls
2
Predicates
6

Its longest line of descent runs back 29 generations to K941811 (1994). 223 ancestors in all, the oldest K844187 (1985). 15 later devices descend from it, 2 citing it directly. 1 of the 239 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2011: 2 other ancestors2009: 1 other ancestor2004: 17 other ancestors2003: 14 other ancestors2008: 2 other ancestors2006: 6 other ancestors2005: 6 other ancestors2002: 15 other ancestors2001: 9 other ancestors1998: 18 other ancestors1994: 3 other ancestors1993: 8 other ancestors1989: 3 other ancestors2007: 1 other ancestor2000: 21 other ancestors1999: 12 other ancestors1997: 9 other ancestors, 1 with a Class I recall11996: 11 other ancestors1995: 10 other ancestors1992: 8 other ancestors1990: 7 other ancestors1987: 2 other ancestors1991: 8 other ancestors1985: 1 other ancestor2014: 1 descendant cleared2022: 3 descendants cleared2017: 1 descendant cleared2016: 2 descendants cleared2018: 1 descendant cleared2020: 1 descendant cleared2025: 2 descendants cleared2021: 1 descendant cleared2024: 2 descendants cleared2026: 1 descendant clearedReference device: K102854 · PC ECG · Edan Instruments, Inc. · 2010Reference device: K092010 · PC Ecg, Model SE-1010 · Edan Instruments, Inc. · 2009K941811 · 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 · 2009K100939 · Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 and MP90 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 20101990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 13 other ancestors3 generations back: 52 other ancestors4 generations back: 43 other ancestors5 generations back: 37 other ancestors, 1 with a Class I recall16 generations back: 18 other ancestors7 generations back: 13 other ancestors8 generations back: 11 other ancestors9 generations back: 1 other ancestor10 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 3 descendants4 generations forward: 3 descendants5 generations forward: 2 descendants6 generations forward: 2 descendants K100939 · 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. · 1994−25−20−15−10−50+5
  1. Root · 29 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 25 generations between
  3. 3 generations backK083517 Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · Recalled
  4. 2 generations backK091927 Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009
  5. 1 generation backK100939 Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
  6. This deviceK113623 Patient MonitorEdan Instruments, Inc. · 2012
  7. Descendant · cites it directly · 14 of its ownK131971 IM60/IM70 Patient MonitorEdan Instruments, Inc. · 2014 · Recalled
  8. Descendant · 2 generations on · 8 of its ownK160981 Patient MonitorEdan Instruments, Inc. · 2016 · Recalled
  9. Descendant · 3 generations on · 6 of its ownK192514 Patient MonitorEdan Instruments, Inc. · 2020 · Recalled
  10. Descendant · 4 generations on · 3 of its ownK202336 Patient MonitorEdan Instruments, Inc. · 2021 · Recalled
  11. Descendant · 5 generations on · 2 of its ownK232962 Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc. · 2024 · Recalled
Show all 29 generations
  1. Root · 29 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 28 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
  3. 27 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
  4. 26 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
  5. 25 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  6. 24 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
  7. 23 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
  8. 22 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
  9. 21 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
  10. 20 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
  11. 19 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
  12. 18 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
  13. 17 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
  14. 16 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
  15. 15 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
  16. 14 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
  17. 13 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
  18. 12 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
  19. 11 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
  20. 10 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
  21. 9 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  22. 8 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
  23. 7 generations backK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
  24. 6 generations backK061610 Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  25. 5 generations backK063315 Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH · 2006
  26. 4 generations backK071426 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
  27. 3 generations backK083517 Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · Recalled
  28. 2 generations backK091927 Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009
  29. 1 generation backK100939 Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
  30. This deviceK113623 Patient MonitorEdan Instruments, Inc. · 2012

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2014: 12016: 22017: 12018: 12020: 12021: 12022: 32024: 22025: 22026: 1
2014high 3 (2022) · low 0 (2015)2026

Class I recalls in this family

  • K970209 Capnocheck Plus5 generations back · 1997

Most influential descendants

Showing 5 of 15 · See all
  • K131971IM60/IM70 Patient MonitorEdan Instruments, Inc. · 2014 · cites it directly14descendants
  • K160981Patient MonitorEdan Instruments, Inc. · 2016 · 2 generations on8descendants
  • K192514Patient MonitorEdan Instruments, Inc. · 2020 · 3 generations on6descendants
  • K202336Patient MonitorEdan Instruments, Inc. · 2021 · 4 generations on3descendants
  • K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc. · 2024 · 5 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−29K941811HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co.1994—
−28K960934HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co.1996—
−27K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co.1999—
−26K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH1999—
−25K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
−24K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—
−23K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…Philips Medical Systems2002—
−22K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002—
−21K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…Philips Medical Systems2002—
−20K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology…Philips Medical Systems, Inc.2003—
−19K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH2003—
−18K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH2003—
−17K040304Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH2004—
−16K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2004—
−15K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient…Philips Medizin Systeme Boblingen GmbH2004—
−14K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2005—
−13K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizin Systeme Boeblingen GmbH2005—
−12K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2005—
−11K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH2005—
−10K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors…Philips Medizin Systeme Boeblingen GmbH2006—
−9K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2006—
−8K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient…Philips Medizin Systeme Boblingen GmbH20062
−7K061052The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc.2006—
−6K061610Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2006—
−5K063315Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80…Philips Medizin Systeme Boeblingen GmbH2006—
−4K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007—
−3K083517Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20092
−2K091927Intellivue 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—
0 (this device)K113623Patient MonitorEdan Instruments, Inc.2012—
+1K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.20142
+2K160981Patient MonitorEdan Instruments, Inc.20161
+3K192514Patient MonitorEdan Instruments, Inc.20201
+4K202336Patient MonitorEdan Instruments, Inc.20211
+5K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.20241

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
198720
198930
199070
199180
199280
199380
199430
1995100
1996110
199791
1998180
1999120
2000210
200190
2002150
2003140
2004170
200560
200660
200710
200820
200910
201120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201620
201710
201810
202010
202110
202230
202420
202520
202610
FIG. 1 — Lineage of K113623, 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? (6)

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
*K100939Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70…
Summary page 2
…Manufacturer Predicate Device 510(k) number Cleared date Philips Medical System MP5 K100939 -April.1.2010 Edan Instruments, Inc M3 and M3A K102825 Dec.27.2010…
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010—
*K102825Blood Pressure Cuff
Summary page 2
…Philips Medical System MP5 K100939 -April.1.2010 Edan Instruments, Inc M3 and M3A K102825 Dec.27.2010 Philips Medical System MP70 K100939 -April.1.2010…
APK Technology Co., Ltd.2011—
*K083821Vital Signs Monitor
Summary page 2
…0 Philips Medical System MP70 K100939 -April.1.2010 Edan Instruments, Inc M3B K083821 May.14,2009 ZOLL Medical Corporation ZOLL M series NIBP K032363 July 30, 2003…
Edan Instruments, Inc.2009—
*K032363Zoll M Series Nibp Option
Summary page 2
…0 Edan Instruments, Inc M3B K083821 May.14,2009 ZOLL Medical Corporation ZOLL M series NIBP K032363 July 30, 2003 option Colin Medical Instruments Corp BX…
Zoll Medical Corp2003—
*K032857Press-Mate BX-10 Vital Sign Monitor
Summary page 2
…series NIBP K032363 July 30, 2003 option Colin Medical Instruments Corp BX-10 K032857 April.21,2003 PHASEIN AB Carbon-dioxide gas K103604 March.28, 2011…
Colin Medical Instruments Corp.2004—
*K103604Isa CO2, Isa AX+, Isa or+
Summary page 2
…Colin Medical Instruments Corp BX-10 K032857 April.21,2003 PHASEIN AB Carbon-dioxide gas K103604 March.28, 2011 analyzer _____________ ___…
Phasein AB2011—
†K102854PC ECGEdan Instruments, Inc.2010—
†K092010PC Ecg, Model SE-1010Edan Instruments, Inc.2009—

Also cleared against K100939: 16 other devices →

What descends from it? (15)

See all 15

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

NumberDeviceApplicantDecidedDescendants
K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.201414
K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220

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

Recalls of this device

DateClassRecallRoot causeReason
Oct 24, 2025Class IIZ-1145-2026Device DesignAs a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Jun 23, 2016Class IIZ-2388-2016Nonconforming Material/ComponentIncorrect CO2 readings with some patient monitors.

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 · 5 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 18 years and passes through 9 companies; a new generation was cleared every 4 months on median.
  • 31 of the 223 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K131971 (Edan Instruments, Inc., 2014) has gone furthest, with 14 descendants of its own.
  • 16 other devices also cite its predicate K100939.

How does its category compare?

All MHX devices

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

FDA decisions per year · MHX

8in 2025

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

2026 to Oct 25, outlined.

Median 510(k) review, days · MHX

192in 2025

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

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

Recalls per year · MHX

21so far in 2026, the most since 2007

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

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

Adverse event reports per year · MHX

3,761in 2025

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

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

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

What is it indicated for?

iMSO: The monitor monitors parameters such as EGG (3-lead, S-lead, 12-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (2/4 channels IBP NIBP), Cardiac Output (GO), Temperature (dual-TEMP), Expired C02 and Anesthetic gas (AG). The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits…

Read the full statement (146 words)

iMSO:

The monitor monitors parameters such as EGG (3-lead, S-lead, 12-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (2/4 channels IBP NIBP), Cardiac Output (GO), Temperature (dual-TEMP), Expired C02 and Anesthetic gas (AG). The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.

iMSO:

The monitor monitors parameters such as ECG (3-lead, 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO 2 ), Invasive or noninvasive blood pressure (dual-IB3P, NIBP), Temperature (dual-TEMP), Expired C02 and Quick Temperature (Quick TEMP. The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.

The arrhythmia detection and ST Segment analysis are not intended for neonatal patients.

Indications for use as stated in the FDA summary.

Also cleared against K100939

16 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
  • K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient Monitor MX500…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 20141 recall
  • K131829Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2013
  • K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 20124 recalls
  • K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2012

More from Edan Instruments, Inc.

94 FDA decisions under this applicant name. See the company

  • K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc. · 2026
  • K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc. · 2026
  • K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc. · 2026
  • K251268Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)Edan Instruments, Inc. · 2025
  • K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc. · 2025

Recent decisions in MHX

The MHX category page

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https://510kreport.com/device/K113623 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113623: Patient Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113623

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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