510(k) Report

510(k) · Cleared

Cleared

Philips M3001A Multi Measurement Server

K090360510(k) SpecialCleared May 4, 200981-day reviewClass II21 CFR 870.2700

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 · DQA Oximeter

Cleared on May 4, 2009 as substantially equivalent to K030973 (Philips Medical Systems, 2003) and 2 other predicates after an 81-day review. Its family tree reaches back 9 generations to 1994. 84 later devices descend from it.

Decided
May 4, 2009
Review
81 days
Class
Class II
Product code
DQA
Recalls
None
Predicates
3

Its longest line of descent runs back 9 generations to K941811 (1994). 54 ancestors in all, the oldest K863784 (1986). 84 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2003: 1 other ancestor2002: 2 other ancestors2001: 1 other ancestor1998: 5 other ancestors1986: 1 other ancestor2000: 9 other ancestors1999: 5 other ancestors1995: 4 other ancestors1993: 2 other ancestors1992: 3 other ancestors1990: 3 other ancestors1989: 1 other ancestor1997: 3 other ancestors1996: 2 other ancestors1987: 1 other ancestor1994: 1 other ancestor2012: 2 descendants cleared2010: 1 descendant cleared2011: 1 descendant cleared2013: 5 descendants cleared2014: 3 descendants cleared2015: 3 descendants cleared2017: 4 descendants cleared2016: 2 descendants cleared2023: 10 descendants cleared2020: 5 descendants cleared2022: 7 descendants cleared2018: 7 descendants cleared2019: 6 descendants cleared2021: 3 descendants cleared2025: 12 descendants cleared2024: 7 descendants cleared2026: 6 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) K013199 · Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276B · Philips Medical Systems, Inc. · 2001K021300 · Modification of Philips Component Compact Monitor, Release a.03, Model M1275B · Philips Medical Systems · 2002K030973 · Picosat II SPO2 Pulse Oximetry Module · Philips Medical Systems · 2003K033715 · Picosat II SP02 Pulse Oximetry Module and M3001A Multi-Measurement Server · Philips Medical Systems, Inc. · 2004 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 6 other ancestors3 generations back: 26 other ancestors4 generations back: 6 other ancestors5 generations back: 5 other ancestors6 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 10 descendants3 generations forward: 4 descendants4 generations forward: 18 descendants5 generations forward: 13 descendants6 generations forward: 11 descendants7 generations forward: 7 descendants8 generations forward: 8 descendants9 generations forward: 5 descendants10 generations forward: 6 descendants K033715 · Picosat II SP02 Pulse Oximetry Module and M3001A Multi-Measurement Server · Philips Medical Systems, Inc. · 2004 · recalledK030973 · Picosat II SPO2 Pulse Oximetry Module · Philips Medical Systems · 2003K021300 · Modification of Philips Component Compact Monitor, Release a.03, 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. · 1994−50+5+10
  1. Root · 9 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 5 generations between
  3. 3 generations backK021300 Modification of Philips Component Compact Monitor, Release a.03…Philips Medical Systems · 2002
  4. 2 generations backK030973 Picosat II SPO2 Pulse Oximetry ModulePhilips Medical Systems · 2003
  5. 1 generation backK033715 Picosat II SP02 Pulse Oximetry Module and M3001A Multi-Measurement…Philips Medical Systems, Inc. · 2004 · Recalled
  6. This deviceK090360 Philips M3001A Multi Measurement ServerPhilips Medizin Systeme Boblingen GmbH · 2009
  7. Descendant · cites it directly · 46 of its ownK120366 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2012
  8. Descendant · 2 generations on · 41 of its ownK122439 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2012 · Recalled
  9. Descendant · 2 generations on · 37 of its ownK131872 Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2013 · Recalled
  10. Descendant · 2 generations on · 37 of its ownK130849 Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2013 · Recalled
  11. Descendant · cites it directly · 37 of its ownK101600 Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
Show all 9 generations
  1. Root · 9 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 8 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
  3. 7 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
  4. 6 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
  5. 5 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  6. 4 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
  7. 3 generations backK021300 Modification of Philips Component Compact Monitor, Release a.03…Philips Medical Systems · 2002
  8. 2 generations backK030973 Picosat II SPO2 Pulse Oximetry ModulePhilips Medical Systems · 2003
  9. 1 generation backK033715 Picosat II SP02 Pulse Oximetry Module and M3001A Multi-Measurement…Philips Medical Systems, Inc. · 2004 · Recalled
  10. This deviceK090360 Philips M3001A Multi Measurement ServerPhilips Medizin Systeme Boblingen GmbH · 2009

Showing 5 of 84 descendants. See all descendants

Descendants cleared per year

2010: 12011: 12012: 22013: 52014: 32015: 32016: 22017: 42018: 72019: 62020: 52021: 32022: 72023: 102024: 72025: 122026: 6
2010high 12 (2025) · low 1 (2010)2026

Most influential descendants

Showing 5 of 84 · See all
  • K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2012 · cites it directly46descendants
  • K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2012 · 2 generations on41descendants
  • K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2013 · 2 generations on37descendants
  • K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2013 · 2 generations on37descendants
  • K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010 · cites it directly37descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K941811HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co.1994—
−8K960934HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co.1996—
−7K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co.1999—
−6K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH1999—
−5K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
−4K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—
−3K021300Modification of Philips Component Compact Monitor, Release a.03, Model M1275BPhilips Medical Systems2002—
−2K030973Picosat II SPO2 Pulse Oximetry ModulePhilips Medical Systems2003—
−1K033715Picosat II SP02 Pulse Oximetry Module and M3001A Multi-Measurement ServerPhilips Medical Systems, Inc.20043
0 (this device)K090360Philips M3001A Multi Measurement ServerPhilips Medizin Systeme Boblingen GmbH2009—
+1K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2012—
+2K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH20124
+2K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20135
+2K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20138
+1K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
198710
198910
199030
199230
199320
199410
199540
199620
199730
199850
199950
200090
200110
200220
200310
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201110
201220
201350
201430
201530
201620
201740
201870
201960
202050
202130
202270
2023100
202470
2025120
202660
FIG. 1 — Lineage of K090360, 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 DQA? 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 DQA device

  1. #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 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? (3)

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
*K030973Picosat II SPO2 Pulse Oximetry Module
Summary page 1
…al environment. 4. The modified device Philips M3001A Multi Measurement Server is substantially equivalent to the legally marketed M3001A Multi Measurement Server (K030973, K033715) . The modification consists of the integration of the Nellcor OxiMax SpO 2 measurement module which is substantia…
Philips Medical Systems2003—
*K033715Picosat II SP02 Pulse Oximetry Module and M3001A Multi-Measurement Server
Summary page 1
…nment. 4. The modified device Philips M3001A Multi Measurement Server is substantially equivalent to the legally marketed M3001A Multi Measurement Server (K030973, K033715) . The modification consists of the integration of the Nellcor OxiMax SpO 2 measurement module which is substantially equiv…
Philips Medical Systems, Inc.20043
*K060576Nellcor Oximax N-600X Pulse Oximeter
Summary page 1
…f the integration of the Nellcor OxiMax SpO 2 measurement module which is substantially equivalent to the legally marketed Nellcor OxiMax N-600x Pulse Oximeter (K060576). 5. The modification adds to the M3001A Multi Measurement Server the Nellcor OxiMax SpO 2 measurement module as an option in…
Nellcor Puritan Bennett, Inc.2006—

Also cleared against K030973: 9 other devices →

What descends from it? (84)

See all 84

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

NumberDeviceApplicantDecidedDescendants
K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201246
K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201037

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 15 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
  • 5 of the 54 ancestors have a recall of any class.
  • Of its descendants, K120366 (Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, 2012) has gone furthest, with 46 descendants of its own.
  • 9 other devices also cite its predicate K030973.

How does its category compare?

All DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · DQA

15in 2025

2007: 202008: 222009: 352010: 292011: 152012: 142013: 152014: 112015: 132016: 142017: 92018: 182019: 192020: 152021: 102022: 202023: 132024: 142025: 152026 (partial year): 8
2007high 35 (2009) · low 9 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQA

182in 2025

2007: 122 days median2008: 97 days median2009: 117 days median2010: 127 days median2011: 195 days median2012: 120 days median2013: 182 days median2014: 175 days median2015: 158 days median2016: 246 days median2017: 200 days median2018: 260 days median2019: 158 days median2020: 126 days median2021: 174 days median2022: 265 days median2023: 317 days median2024: 285 days median2025: 182 days median2026 (partial year): 187 days median
2007high 317 (2023) · low 97 (2008)2026

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

Recalls per year · DQA

3in 2024

2007: 62008: 52009: 292010: 42011: 12014: 22015: 12018: 322024: 3
2007high 32 (2018) · low 0 (2012)2026

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

Adverse event reports per year · DQA

399in 2025

2007: 3252008: 3122009: 2812010: 1852011: 1642012: 3222013: 4682014: 1,1242015: 2,0822016: 1,7752017: 1,1902018: 6942019: 5482020: 4262021: 5532022: 4782023: 3922024: 5452025: 399
2007high 2,082 (2015) · low 164 (2011)2025

MAUDE reports naming product code DQA, 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
2007201226325
200822975312
20093511729281
2010291274185
2011151951164
2012141200322
2013151820468
20141117521,124
20151315812,082
20161424601,775
2017920001,190
20181826032694
2019191580548
2020151260426
2021101740553
2022202650478
2023133170392
2024142853545
2025151820399
202681870—

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 adult, pediatric and neonatal patients in a hospital environment and during transport inside and outside of hospital environment.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K090360: Philips M3001A Multi Measurement Server.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090360

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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