510(k) Report

510(k) · Cleared

Cleared

Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse Oximetry Module

K081937510(k) SpecialCleared Aug 29, 200853-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 Boeblingen GmbH · DQA Oximeter

Cleared on Aug 29, 2008 as substantially equivalent to K033715 (Philips Medical Systems, Inc., 2004) and 2 other predicates after a 53-day review. Its family tree reaches back 27 generations to 1994. 49 later devices descend from it.

Decided
Aug 29, 2008
Review
53 days
Class
Class II
Product code
DQA
Recalls
None
Predicates
3

Its longest line of descent runs back 27 generations to K941811 (1994). 172 ancestors in all, the oldest K844187 (1985). 49 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 12 other ancestors2002: 13 other ancestors2007: 1 other ancestor2006: 4 other ancestors2003: 12 other ancestors2001: 7 other ancestors2000: 19 other ancestors1998: 13 other ancestors1995: 6 other ancestors2005: 2 other ancestors1999: 10 other ancestors1997: 7 other ancestors1993: 5 other ancestors1992: 6 other ancestors1990: 6 other ancestors1989: 2 other ancestors1996: 10 other ancestors1994: 2 other ancestors1987: 1 other ancestor1991: 6 other ancestors1985: 1 other ancestor2011: 3 descendants cleared2009: 1 descendant cleared2010: 1 descendant cleared2013: 5 descendants cleared2012: 1 descendant cleared2021: 3 descendants cleared2015: 2 descendants cleared2023: 4 descendants cleared2020: 3 descendants cleared2014: 1 descendant cleared2022: 5 descendants cleared2018: 3 descendants cleared2017: 1 descendant cleared2025: 6 descendants cleared2019: 2 descendants cleared2024: 6 descendants cleared2026: 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), K061610 (2006), K063315 (2006) ×2: 2 generations cleared close together, K071426 (2007), K072070 (2007) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 9 other ancestors3 generations back: 24 other ancestors4 generations back: 32 other ancestors5 generations back: 26 other ancestors6 generations back: 17 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: 3 descendants2 generations forward: 6 descendants3 generations forward: 4 descendants4 generations forward: 7 descendants5 generations forward: 5 descendants6 generations forward: 4 descendants7 generations forward: 4 descendants8 generations forward: 5 descendants9 generations forward: 5 descendants10 generations forward: 6 descendants K072070 · Philips MP2 and X2 Intellivue Patient Monitors · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007K071426 · 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+10
  1. Root · 27 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 23 generations between
  3. 3 generations backK063315 Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH · 2006
  4. 2 generations backK071426 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
  5. 1 generation backK072070 Philips MP2 and X2 Intellivue Patient MonitorsPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
  6. This deviceK081937 Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules…Philips Medizin Systeme Boeblingen GmbH · 2008
  7. 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
  8. Descendant · 2 generations on · 36 of its ownK111905 Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011
  9. Descendant · 3 generations on · 35 of its ownK122223 New: Intellivue CL Respiration Pod New: Specialized Assessory…Philips Medizin Systeme Boeblingen GmbH · 2013
  10. Descendant · 4 generations on · 24 of its ownK151736 Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH · 2015
  11. Descendant · 5 generations on · 23 of its ownK161767 Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH · 2017
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 backK061610 Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  25. 3 generations backK063315 Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH · 2006
  26. 2 generations backK071426 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
  27. 1 generation backK072070 Philips MP2 and X2 Intellivue Patient MonitorsPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
  28. This deviceK081937 Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules…Philips Medizin Systeme Boeblingen GmbH · 2008

Showing 5 of 49 descendants. See all descendants

Descendants cleared per year

2009: 12010: 12011: 32012: 12013: 52014: 12015: 22017: 12018: 32019: 22020: 32021: 32022: 52023: 42024: 62025: 62026: 2
2009high 6 (2024) · low 0 (2016)2026

Most influential descendants

Showing 5 of 49 · See all
  • K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010 · cites it directly37descendants
  • K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · 2 generations on36descendants
  • K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH · 2013 · 3 generations on35descendants
  • K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH · 2015 · 4 generations on24descendants
  • K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH · 2017 · 5 generations on23descendants
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—
−4K061610Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2006—
−3K063315Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80…Philips Medizin Systeme Boeblingen GmbH2006—
−2K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007—
−1K072070Philips MP2 and X2 Intellivue Patient MonitorsPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007—
0 (this device)K081937Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse…Philips Medizin Systeme Boeblingen GmbH2008—
+1K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010—
+2K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2011—
+3K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp…Philips Medizin Systeme Boeblingen GmbH2013—
+4K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH2015—
+5K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH2017—

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
200170
2002130
2003120
2004120
200520
200640
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
201130
201210
201350
201410
201520
201710
201830
201920
202030
202130
202250
202340
202460
202560
202620
FIG. 1 — Lineage of K081937, 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 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
*K033715Picosat II SP02 Pulse Oximetry Module and M3001A Multi-Measurement Server
Summary page 1
…002A) Multi-Measurement Module is indicated for transport monitoring outside hospitals. 4. The modified device is substantially equivalent to predicate devices K033715 picoSAT II SPO2 pulse oximetry module, K021300 M3001A Multi-Measurement Server, K072070 X2 (M3002A) Multi- Measurement Modu…
Philips Medical Systems, Inc.20043
*K021300Modification of Philips Component Compact Monitor, Release a.03, Model M1275B
Summary page 1
…for transport monitoring outside hospitals. 4. The modified device is substantially equivalent to predicate devices K033715 picoSAT II SPO2 pulse oximetry module, K021300 M3001A Multi-Measurement Server, K072070 X2 (M3002A) Multi- Measurement Module containing the picoSAT II SpO2 pulse oximetr…
Philips Medical Systems2002—
*K072070Philips MP2 and X2 Intellivue Patient Monitors
Summary page 1
…s. 4. The modified device is substantially equivalent to predicate devices K033715 picoSAT II SPO2 pulse oximetry module, K021300 M3001A Multi-Measurement Server, K072070 X2 (M3002A) Multi- Measurement Module containing the picoSAT II SpO2 pulse oximetry module. 5. The modified devices have th…
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007—

Also cleared against K033715: 4 other devices →

What descends from it? (49)

See all 49

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

NumberDeviceApplicantDecidedDescendants
K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201037
K090785Mri Compatible Patient Monitoring System, Model 865214Invivo Corp.20099
K103285Dixtal DZ-4100 Series Pulse OximeterDixtal Medical, Inc.20110

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 14 years and passes through 8 companies; a new generation was cleared every 3 months on median.
  • 20 of the 172 ancestors have a recall of any class.
  • Of its descendants, K101600 (Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, 2010) has gone furthest, with 37 descendants of its own.
  • 4 other devices also cite its predicate K033715.

How does its category compare?

All DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 whenever there is a need for monitoring, transport monitoring, recording, and alarming of the physiological parameters arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric and neonatal patients in a hospital environment by health care professionals.

X2 (M3002A) Multi-Measurement Module is indicated for transport monitoring outside hospitals.

Indications for use as stated in the FDA summary.

Also cleared against K033715

4 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
  • K090360Philips M3001A Multi Measurement ServerPhilips Medizin Systeme Boblingen GmbH · 2009
  • K062392Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2006
  • K052795Philips Avalon Fetal Monitor, Models FM20 and FM30Philips Medizin Systeme Boeblingen GmbH · 20051 recall

More from Philips Medizin Systeme Boeblingen GmbH

48 FDA decisions under this applicant name. See the company

  • K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX…Philips Medizin Systeme Boeblingen GmbH · 2026
  • K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH · 2025
  • K233440Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)Philips Medizin Systeme Boeblingen GmbH · 2024
  • K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH · 2023
  • K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH · 2023

Recent decisions in DQA

The DQA category page

  • K260490Ninenovo Blood Oxygen Ring…Shenzhen Ninenovo Technology Limited · 2026
  • K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbH · 2026
  • K252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd. · 2026
  • K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor…Philips Medizin Systeme · 2026
  • K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc. · 2026

https://510kreport.com/device/K081937 · printed Nov 5, 2026

Cite this page

510(k) Report. “K081937: Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse Oximetry Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081937

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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