510(k) Report

510(k) · Cleared

Recalled · Class II · 2023

Intellivue MX40 Patient Monitor

K113125510(k) SpecialCleared Nov 17, 201124-day reviewClass II21 CFR 870.1025Recalls 16

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

Philips Medical Systems · DSI Detector And Alarm, Arrhythmia

Cleared on Nov 17, 2011 as substantially equivalent to K103646 (Phillips Medical Systems, 2011) after a 24-day review. Its family tree reaches back 27 generations to 1994. 14 later devices descend from it. It has been recalled 16 times.

Decided
Nov 17, 2011
Review
24 days
Class
Class II
Product code
DSI
Recalls
16
Predicates
1

Its longest line of descent runs back 27 generations to K941811 (1994). 168 ancestors in all, the oldest K844187 (1985). 14 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 13 other ancestors2005: 2 other ancestors2003: 11 other ancestors2002: 13 other ancestors2000: 19 other ancestors1999: 10 other ancestors1998: 13 other ancestors2006: 2 other ancestors2001: 6 other ancestors1997: 7 other ancestors1996: 10 other ancestors1995: 6 other ancestors1993: 5 other ancestors1991: 6 other ancestors1989: 2 other ancestors1992: 6 other ancestors1990: 6 other ancestors1994: 2 other ancestors1987: 1 other ancestor1985: 1 other ancestor2017: 1 descendant cleared2020: 1 descendant cleared2018: 1 descendant cleared2025: 3 descendants cleared2023: 2 descendants cleared2022: 1 descendant cleared2026: 3 descendants cleared2024: 2 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), K062392 (2006), K063725 (2007) K081793 · Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry System Transceiver · Philips Medizin Systeme Boeblingen GmbH · 2008K103646 · Intellivue MX40 Patient Monitor · Phillips Medical Systems · 2011 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 2 other ancestors3 generations back: 10 other ancestors4 generations back: 34 other ancestors5 generations back: 33 other ancestors6 generations back: 27 other ancestors7 generations back: 14 other ancestors8 generations back: 12 other ancestors9 generations back: 8 other ancestors10 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 5 descendants4 generations forward: 4 descendants5 generations forward: 2 descendants K103646 · Intellivue MX40 Patient Monitor · Phillips Medical Systems · 2011 · recalledK081793 · Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry System Transceiver · Philips Medizin Systeme Boeblingen GmbH · 2008K063725 · MP5 Intellivue Patient Monitor · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007K062392 · Philips MP5 Intellivue Patient Monitor · 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 · 27 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 23 generations between
  3. 3 generations backK063725 MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
  4. 2 generations backK081793 Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A…Philips Medizin Systeme Boeblingen GmbH · 2008
  5. 1 generation backK103646 Intellivue MX40 Patient MonitorPhillips Medical Systems · 2011 · Recalled
  6. This deviceK113125 Intellivue MX40 Patient MonitorPhilips Medical Systems · 2011
  7. Descendant · cites it directly · 13 of its ownK172226 MX40 Release B.07Philips Medical Systems · 2017
  8. Descendant · 2 generations on · 10 of its ownK193391 BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2020 · Recalled
  9. Descendant · 3 generations on · 3 of its ownK220058 BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2022 · Recalled
  10. Descendant · 3 generations on · 2 of its ownK223567 CNS-2101 Central MonitorNihon Kohden Corporation · 2023
  11. Descendant · 4 generations on · 1 of its ownK242750 Central StationNihon Kohden Digital Health Solutions, LLC · 2025
Show all 27 generations
  1. Root · 27 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 26 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
  3. 25 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
  4. 24 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
  5. 23 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  6. 22 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
  7. 21 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
  8. 20 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
  9. 19 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
  10. 18 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
  11. 17 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
  12. 16 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
  13. 15 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
  14. 14 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
  15. 13 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
  16. 12 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
  17. 11 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
  18. 10 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
  19. 9 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
  20. 8 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
  21. 7 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  22. 6 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
  23. 5 generations backK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
  24. 4 generations backK062392 Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2006
  25. 3 generations backK063725 MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
  26. 2 generations backK081793 Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A…Philips Medizin Systeme Boeblingen GmbH · 2008
  27. 1 generation backK103646 Intellivue MX40 Patient MonitorPhillips Medical Systems · 2011 · Recalled
  28. This deviceK113125 Intellivue MX40 Patient MonitorPhilips Medical Systems · 2011

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2017: 12018: 12020: 12022: 12023: 22024: 22025: 32026: 3
2017high 3 (2025) · low 0 (2019)2026

Most influential descendants

Showing 5 of 14 · See all
  • K172226MX40 Release B.07Philips Medical Systems · 2017 · cites it directly13descendants
  • K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2020 · 2 generations on10descendants
  • K220058BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2022 · 3 generations on3descendants
  • K223567CNS-2101 Central MonitorNihon Kohden Corporation · 2023 · 3 generations on2descendants
  • K242750Central StationNihon Kohden Digital Health Solutions, LLC · 2025 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−27K941811HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co.1994—
−26K960934HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co.1996—
−25K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co.1999—
−24K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH1999—
−23K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
−22K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—
−21K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…Philips Medical Systems2002—
−20K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002—
−19K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…Philips Medical Systems2002—
−18K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology…Philips Medical Systems, Inc.2003—
−17K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH2003—
−16K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH2003—
−15K040304Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH2004—
−14K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2004—
−13K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient…Philips Medizin Systeme Boblingen GmbH2004—
−12K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2005—
−11K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizin Systeme Boeblingen GmbH2005—
−10K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2005—
−9K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH2005—
−8K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors…Philips Medizin Systeme Boeblingen GmbH2006—
−7K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2006—
−6K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient…Philips Medizin Systeme Boblingen GmbH20062
−5K061052The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc.2006—
−4K062392Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2006—
−3K063725MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007—
−2K081793Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue…Philips Medizin Systeme Boeblingen GmbH2008—
−1K103646Intellivue MX40 Patient MonitorPhillips Medical Systems20111
0 (this device)K113125Intellivue MX40 Patient MonitorPhilips Medical Systems2011—
+1K172226MX40 Release B.07Philips Medical Systems2017—
+2K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20202
+3K220058BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20221
+3K223567CNS-2101 Central MonitorNihon Kohden Corporation2023—
+4K242750Central StationNihon Kohden Digital Health Solutions, LLC2025—

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
200160
2002130
2003110
2004130
200520
200620

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
201810
202010
202210
202320
202420
202530
202630
FIG. 1 — Lineage of K113125, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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
Get a 510(k) Report

What was it cleared against? (1)

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
*K103646Intellivue MX40 Patient Monitor
Summary page 1
…§870.2910, 11 DRO Radiofreguency The modified device is substantially equivalent to the previously cleared MX40 IntelliVue Patient Monitor (K 103646). Updated compatibility to lead sets and other devices. Intended for monitoring and recording of and to generate alarms for, mul…
Phillips Medical Systems20111

Also cleared against K103646: 2 other devices →

What descends from it? (14)

See all 14

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K172226MX40 Release B.07Philips Medical Systems201713

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

Recalls of this device

DateClassRecallRoot causeReason
Apr 19, 2023Class IIZ-0035-2025Software designDuring extended operation of the MX40 with the PIC iX, the DHCP (Dynamic Host Configuration Protocol) lease can expire on the MX40. If the DHCP lease expires while the device is offline, upon reconnecting with the PIC iX, a new IP address…
Feb 2, 2021Class IIZ-1671-2021Employee errorManufacturing failed to follow process steps resulting in the distribution of potentially defective devices
Mar 28, 2019Class IIZ-1694-2019Software designThe MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .
Mar 28, 2019Class IIZ-1692-2019Software designThe MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .
Mar 28, 2019Class IIZ-1693-2019Software designThe MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .
Mar 28, 2019Class IIZ-1695-2019Software designThe MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .
Oct 10, 2018Class IIZ-0592-2019Vendor change controlA problem has been detected in the Philips IntelliVue MX4O that, if it were to occur, could affect the performance of the equipment. The volume of the MX4O speaker in these devices may be diminished or not audible above 4,500 feet when…
Apr 30, 2018Class IIZ-2142-2018Error in labelingFive warning statements are missing from the instructions for use.
Apr 30, 2018Class IIZ-2143-2018Error in labelingFive warning statements are missing from the instructions for use.
Apr 30, 2018Class IIZ-2144-2018Error in labelingFive warning statements are missing from the instructions for use.
Apr 30, 2018Class IIZ-2141-2018Error in labelingFive warning statements are missing from the instructions for use.
Mar 6, 2017Class IIZ-1707-2017Software designPhilips lntelliVue MX4O WLAN Patient Wearable Monitor may not automatically switch to Monitor Mode with audible alarms when association with central monitoring system is unsuccessful [incomplete]
Sep 19, 2016Class IIZ-0293-2017Software designPhilips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and Delivery of ECG Alarms to PIIC iX
Sep 19, 2016Class IIZ-0291-2017Software designPhilips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and Delivery of ECG Alarms to PIIC iX
Sep 19, 2016Class IIZ-0292-2017Software designPhilips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and Delivery of ECG Alarms to PIIC iX
May 22, 2014Class IIZ-1746-2014Software designIntelliVue MX40 (part numbers 865350, 865352) with software revisions B.00 or B.01 may not resume alarming when the alarms are paused and the pause timer ends.

The 5 latest of 16 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 17 years and passes through 9 companies; a new generation was cleared every 4 months on median.
  • 22 of the 168 ancestors have a recall of any class.
  • Of its descendants, K172226 (Philips Medical Systems, 2017) has gone furthest, with 13 descendants of its own.
  • 2 other devices also cite its predicate K103646.

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. 2011, 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 and pediatrics in hospital environments and during transport inside hospitals.

Indications for use as stated in the FDA summary.

Also cleared against K103646

2 other devices cite the same predicate.

  • K172226MX40 Release B.07Philips Medical Systems · 2017
  • K123472Cimva UniversalTherapeutic Monitoring Systems (Tms), Inc. · 2013

More from Philips Medical Systems

127 FDA decisions under this applicant name. See the company

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  • P180028/S017HeartStart FRx Defibrillator and HeartStart SMART Pads IIPhilips Medical Systems · 2025
  • P180028/S016HeartStart FRx Defibrillator (861304)Philips Medical Systems · 2025
  • P180028/S015HeartStart FRx DefibrillatorPhilips Medical Systems · 2025

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/K113125 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113125: Intellivue MX40 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/K113125

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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