510(k) Report

510(k) · Cleared

Cleared

The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O.

K032858510(k) SpecialCleared Oct 10, 200328-day reviewClass II21 CFR 870.1025

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

Philips Medizin Systeme Boblingen GmbH · DSI Detector And Alarm, Arrhythmia

Cleared on Oct 10, 2003 as substantially equivalent to K001664 (Agilent Technologies, Inc., 2000) and 3 other predicates after a 28-day review. Its family tree reaches back 11 generations to 1994. 375 later devices descend from it.

Decided
Oct 10, 2003
Review
28 days
Class
Class II
Product code
DSI
Recalls
None
Predicates
4

Its longest line of descent runs back 11 generations to K941811 (1994). 53 ancestors in all, the oldest K872781 (1987). 375 later devices descend from it, 37 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 10 other ancestors2002: 2 other ancestors1999: 6 other ancestors2001: 2 other ancestors1998: 3 other ancestors1997: 3 other ancestors1995: 3 other ancestors1994: 2 other ancestors1993: 2 other ancestors1992: 4 other ancestors1990: 2 other ancestors1989: 1 other ancestor1996: 1 other ancestor1987: 1 other ancestor2007: 6 descendants cleared2012: 18 descendants cleared2005: 7 descendants cleared2006: 13 descendants cleared2009: 14 descendants cleared2011: 18 descendants cleared2010: 19 descendants cleared2004: 6 descendants cleared2013: 15 descendants cleared2008: 12 descendants cleared2015: 13 descendants cleared2003: 1 descendant cleared2017: 16 descendants cleared2021: 16 descendants cleared2016: 16 descendants cleared2018: 23 descendants cleared2014: 14 descendants cleared2022: 26 descendants cleared2020: 14 descendants cleared2023: 24 descendants cleared2019: 16 descendants cleared2025: 28 descendants cleared2024: 22 descendants cleared2026: 18 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) ×6: 6 generations cleared close together, K013199 (2001), K020531 (2002), K021778 (2002), K023871 (2002), K030038 (2003), K031481 (2003) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 4 other ancestors3 generations back: 29 other ancestors4 generations back: 8 other ancestors 1 generation forward: 37 descendants2 generations forward: 50 descendants3 generations forward: 73 descendants4 generations forward: 67 descendants5 generations forward: 52 descendants6 generations forward: 47 descendants7 generations forward: 33 descendants8 generations forward: 15 descendants9 generations forward: 1 descendant K031481 · 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. · 1994−10−50+5
  1. Root · 11 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 7 generations between
  3. 3 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
  4. 2 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
  5. 1 generation backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
  6. This deviceK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
  7. Descendant · cites it directly · 312 of its ownK040259 Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp. · 2004
  8. Descendant · cites it directly · 253 of its ownK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
  9. Descendant · cites it directly · 252 of its ownK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
  10. Descendant · cites it directly · 251 of its ownK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
  11. Descendant · cites it directly · 250 of its ownK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
Show all 11 generations
  1. Root · 11 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 10 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
  3. 9 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
  4. 8 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
  5. 7 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  6. 6 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
  7. 5 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
  8. 4 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
  9. 3 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
  10. 2 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
  11. 1 generation backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
  12. This deviceK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003

Showing 5 of 375 descendants. See all descendants

Descendants cleared per year

2003: 12004: 62005: 72006: 132007: 62008: 122009: 142010: 192011: 182012: 182013: 152014: 142015: 132016: 162017: 162018: 232019: 162020: 142021: 162022: 262023: 242024: 222025: 282026: 18
2003high 28 (2025) · low 1 (2003)2026

Most influential descendants

Showing 5 of 375 · See all
  • K040259Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp. · 2004 · cites it directly312descendants
  • K040304Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004 · cites it directly253descendants
  • K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH · 2004 · cites it directly252descendants
  • K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boblingen GmbH · 2004 · cites it directly251descendants
  • K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH · 2005 · cites it directly250descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K941811HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co.1994—
−10K960934HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co.1996—
−9K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co.1999—
−8K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH1999—
−7K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
−6K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—
−5K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…Philips Medical Systems2002—
−4K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002—
−3K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…Philips Medical Systems2002—
−2K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology…Philips Medical Systems, Inc.2003—
−1K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH2003—
0 (this device)K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH2003—
+1K040259Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp.2004—
+1K040304Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH2004—
+1K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2004—
+1K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient…Philips Medizin Systeme Boblingen GmbH2004—
+1K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
198910
199020
199240
199320
199420
199530
199610
199730
199830
199960
2000100
200120
200220

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200460
200570
2006130
200760
2008120
2009140
2010190
2011180
2012180
2013150
2014140
2015130
2016160
2017160
2018230
2019160
2020140
2021160
2022260
2023240
2024220
2025280
2026180
FIG. 1 — Lineage of K032858, 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? (4)

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
*K001664Compact Portable Patient Monitor with Wireless Alan, Model Alilent M3000A/M3046A Option…
Summary page 2
…Electroencephalogram Signal 3. The new devices are substantially equivalent to previously cleared Philips devices marketed pursuant to K001664, K021778, KO30038 and K031481. 4. The modification is the introduction of Release B . 0 software for the IntelliVue patien…
Agilent Technologies, Inc.2000—
*K021778Philips Component Compact Monitor, Release a.04, Model #M1275B
Summary page 2
…Electroencephalogram Signal 3. The new devices are substantially equivalent to previously cleared Philips devices marketed pursuant to K001664, K021778, KO30038 and K031481. 4. The modification is the introduction of Release B . 0 software for the IntelliVue patient monitor de…
Philips Medical Systems2002—
*K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185…Philips Medical Systems, Inc.2003—
*K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20
Summary page 2
…ectroencephalogram Signal 3. The new devices are substantially equivalent to previously cleared Philips devices marketed pursuant to K001664, K021778, KO30038 and K031481. 4. The modification is the introduction of Release B . 0 software for the IntelliVue patient monitor devices, MP60, MP70 and…
Philips Medizin Systeme Boblingen GmbH2003—

Also cleared against K001664: 4 other devices →

What descends from it? (375)

See all 375

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

NumberDeviceApplicantDecidedDescendants
K040259Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp.2004312
K040304Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH2004253
K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2004252
K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boblingen GmbH2004251
K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2005250
K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90Philips Medizin Systeme Boeblingen GmbH2005249
K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2005247
K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH2005234
K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00Philips Medizin Systeme Boeblingen GmbH2006233
K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2006222

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 9 years and passes through 5 companies; a new generation was cleared every 4 months on median.
  • 2 of the 53 ancestors have a recall of any class.
  • Of its descendants, K040259 (Masimo Corp., 2004) has gone furthest, with 312 descendants of its own.
  • 4 other devices also cite its predicate K001664.

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.

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, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in hospital environments.

EASI 12-lead ECG is only for use on adult and pediatric patients.

ST Segment monitoring is restricted to adult patients only.

The transcutaneous gas measurement (tcp02 / tcpC02) is restricted to neonatal patients only.

Indications for use as stated in the FDA summary.

Also cleared against K001664

4 other devices cite the same predicate.

  • K040955M3290A Intellivue Information Center Software Release E.01 and Intellivue Clinical Network on VlanPhilips Medical Systems, Inc. · 2004
  • K040304Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
  • K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH · 2003
  • K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185 Opt C41 Wireless…Philips Medical Systems, Inc. · 2003

More from Philips Medizin Systeme Boblingen GmbH

12 FDA decisions under this applicant name. See the company

  • K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH · 2015
  • K140535Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizin Systeme Boblingen GmbH · 20145 recalls
  • K113657Intellivue Patient MonitorPhilips Medizin Systeme Boblingen GmbH · 2012
  • K102958Philips Avalon Fetal MonitorPhilips Medizin Systeme Boblingen GmbH · 2011
  • K102562Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, & MX800Philips Medizin Systeme Boblingen GmbH · 2010

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/K032858 · printed Nov 4, 2026

Cite this page

510(k) Report. “K032858: The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032858

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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