510(k) Report

510(k) · Cleared

Cleared

Philips Medical Systems, M3012A- Hemodynamic Extension to the Multi-Measurement Server

K033444510(k) SpecialCleared Nov 21, 200323-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 Medical Systems · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Nov 21, 2003 as substantially equivalent to K882609 (Waltham Div. Hewlett Packard, 1989) and 4 other predicates after a 23-day review. Its family tree reaches back 12 generations to 1994. 156 later devices descend from it.

Decided
Nov 21, 2003
Review
23 days
Class
Class II
Product code
MHX
Recalls
None
Predicates
5

Its longest line of descent runs back 12 generations to K941811 (1994). 55 ancestors in all, the oldest K872781 (1987). 156 later devices descend from it, 13 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 3 other ancestors2000: 10 other ancestors1989: 1 other ancestor1998: 3 other ancestors2002: 2 other ancestors1999: 6 other ancestors1997: 3 other ancestors1993: 2 other ancestors1992: 4 other ancestors1990: 2 other ancestors1996: 1 other ancestor1995: 3 other ancestors1994: 2 other ancestors1987: 1 other ancestor2007: 2 descendants cleared2012: 8 descendants cleared2009: 5 descendants cleared2011: 6 descendants cleared2008: 2 descendants cleared2010: 5 descendants cleared2017: 9 descendants cleared2013: 9 descendants cleared2015: 7 descendants cleared2014: 9 descendants cleared2016: 9 descendants cleared2021: 6 descendants cleared2018: 10 descendants cleared2019: 6 descendants cleared2023: 11 descendants cleared2020: 6 descendants cleared2022: 13 descendants cleared2025: 15 descendants cleared2026: 7 descendants cleared2024: 11 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) ×7: 7 generations cleared close together, K013199 (2001), K020531 (2002), K021778 (2002), K023871 (2002), K030038 (2003), K031481 (2003), K032858 (2003) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 3 other ancestors3 generations back: 18 other ancestors4 generations back: 19 other ancestors 1 generation forward: 13 descendants2 generations forward: 27 descendants3 generations forward: 26 descendants4 generations forward: 31 descendants5 generations forward: 21 descendants6 generations forward: 12 descendants7 generations forward: 11 descendants8 generations forward: 9 descendants9 generations forward: 6 descendants K032858 · 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. · 1994−10−50+5
  1. Root · 12 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 8 generations between
  3. 3 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
  4. 2 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
  5. 1 generation backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
  6. This deviceK033444 Philips Medical Systems, M3012A- Hemodynamic Extension to the…Philips Medical Systems · 2003
  7. Descendant · cites it directly · 151 of its ownK071426 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
  8. Descendant · cites it directly · 127 of its ownK082633 Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2008 · Recalled
  9. Descendant · cites it directly · 125 of its ownK083517 Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · Recalled
  10. Descendant · cites it directly · 124 of its ownK091927 Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009
  11. Descendant · 2 generations on · 123 of its ownK100939 Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
Show all 12 generations
  1. Root · 12 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 11 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
  3. 10 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
  4. 9 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
  5. 8 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  6. 7 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
  7. 6 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
  8. 5 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
  9. 4 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
  10. 3 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
  11. 2 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
  12. 1 generation backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
  13. This deviceK033444 Philips Medical Systems, M3012A- Hemodynamic Extension to the…Philips Medical Systems · 2003

Showing 5 of 156 descendants. See all descendants

Descendants cleared per year

2007: 22008: 22009: 52010: 52011: 62012: 82013: 92014: 92015: 72016: 92017: 92018: 102019: 62020: 62021: 62022: 132023: 112024: 112025: 152026: 7
2007high 15 (2025) · low 2 (2007)2026

Most influential descendants

Showing 5 of 156 · See all
  • K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007 · cites it directly151descendants
  • K082633Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2008 · cites it directly127descendants
  • K083517Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · cites it directly125descendants
  • K091927Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · cites it directly124descendants
  • K100939Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010 · 2 generations on123descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K941811HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co.1994—
−11K960934HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co.1996—
−10K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co.1999—
−9K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH1999—
−8K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
−7K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—
−6K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…Philips Medical Systems2002—
−5K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002—
−4K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…Philips Medical Systems2002—
−3K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology…Philips Medical Systems, Inc.2003—
−2K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH2003—
−1K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH2003—
0 (this device)K033444Philips Medical Systems, M3012A- Hemodynamic Extension to the…Philips Medical Systems2003—
+1K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007—
+1K082633Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20083
+1K083517Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20092
+1K091927Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009—
+2K100939Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
198910
199020
199240
199320
199420
199530
199610
199730
199830
199960
2000100
200130
200220

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200720
200820
200950
201050
201160
201280
201390
201490
201570
201690
201790
2018100
201960
202060
202160
2022130
2023110
2024110
2025150
202670
FIG. 1 — Lineage of K033444, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MHX? 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? (5)

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
*K882609Models M1175A & M1176A Component Monitoring System
Summary page 1
…l Isolation 880.2910 Thermometer, electronic, clinical 3. The new device is substantially equivalent to previously cleared devices marketed pursuant to K882609, K002758, K020531, K032858, and K992273. 4. The modification is the creation of a new measurement extension for t…
Waltham Div. Hewlett Packard1989—
*K002758Agilent Component Monitoring System, Agilent Cardiac Output Module, Agilent Invasive…
Summary page 1
…on 880.2910 Thermometer, electronic, clinical 3. The new device is substantially equivalent to previously cleared devices marketed pursuant to K882609, K002758, K020531, K032858, and K992273. 4. The modification is the creation of a new measurement extension for the Philip…
Agilent Technologies Deutschland GmbH2001—
*K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact Monitor, Release…
Summary page 1
…0 Thermometer, electronic, clinical 3. The new device is substantially equivalent to previously cleared devices marketed pursuant to K882609, K002758, K020531, K032858, and K992273. 4. The modification is the creation of a new measurement extension for the Philips patient monit…
Philips Medical Systems2002—
*K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O.
Summary page 1
…mometer, electronic, clinical 3. The new device is substantially equivalent to previously cleared devices marketed pursuant to K882609, K002758, K020531, K032858, and K992273. 4. The modification is the creation of a new measurement extension for the Philips patient monitor family…
Philips Medizin Systeme Boblingen GmbH2003—
*K992273HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor…
Summary page 1
…tronic, clinical 3. The new device is substantially equivalent to previously cleared devices marketed pursuant to K882609, K002758, K020531, K032858, and K992273. 4. The modification is the creation of a new measurement extension for the Philips patient monitor family (supported…
Hewlett-Packard GmbH2000—

Also cleared against K882609: 7 other devices →

What descends from it? (156)

See all 156

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

NumberDeviceApplicantDecidedDescendants
K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007151
K082633Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2008127
K083517Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009125
K091927Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009124
K093268Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2010105
K102562Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boblingen GmbH2010103
K082583Intellivue Patient Monitor, Intellibridge Module, Models MP40, MP50, MP60, MP70, MP80…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN200994
K110622Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201190
K113657Intellivue Patient MonitorPhilips Medizin Systeme Boblingen GmbH201281
K113441Physiological Monitor, Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201278

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 55 ancestors have a recall of any class.
  • Of its descendants, K071426 (Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, 2007) has gone furthest, with 151 descendants of its own.
  • 7 other devices also cite its predicate K882609.

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.

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?

Indications for Use (M3046A): For monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in hospital and/or medical transport environments.

Indications for Use (MP40/50/60/70/90): Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in hospital environments.

Indications for use as stated in the FDA summary.

Also cleared against K882609

7 other devices cite the same predicate.

  • K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue Patient Monitors MP5…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
  • K042306Philips SP02 Disposable Sensor, Model M1131APhilips Medizin Systeme Boeblingen GmbH · 2004
  • K032979Philips SPO2 Reusable Sensors, Model Nos. M1191T, M1192T, and M1193TPhilips Medical Systems, Inc. · 2004
  • K013624Modification to Agilent Component Monitoring System (CMS), V24/V26 Patient Monitors, Blood Analysis Portal…Philips Medizin Systeme Boblingen GmbH · 2001
  • K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276BPhilips Medical Systems, Inc. · 2001
  • K952912Spacelabs Medical Integrated Multi-Parameter ModuleSpacelabs Medical, Inc. · 1997

More from Philips Medical Systems

127 FDA decisions under this applicant name. See the company

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  • P180028/S018HeartStart FRx DefibrillatorPhilips Medical Systems · 2026
  • 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 MHX

The MHX category page

  • K260676Radius VSM and AccessoriesMasimo Corporation · 2026
  • K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM…GE Healthcare Finland Oy · 2026
  • K260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland Oy · 2026
  • K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc. · 2026
  • K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc. · 2026

https://510kreport.com/device/K033444 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033444: Philips Medical Systems, M3012A- Hemodynamic Extension to the Multi-Measurement Server.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033444

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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