510(k) Report

510(k) · Cleared

Cleared

Philips SP02 Disposable Sensor, Model M1131A

K042306510(k) AbbreviatedCleared Oct 15, 200451-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 Oct 15, 2004 as substantially equivalent to K882609 (Waltham Div. Hewlett Packard, 1989) and 3 other predicates after a 51-day review. Its family tree reaches back 6 generations to 1994. 76 later devices descend from it.

Decided
Oct 15, 2004
Review
51 days
Class
Class II
Product code
DQA
Recalls
None
Predicates
4

Its longest line of descent runs back 6 generations to K941811 (1994). 17 ancestors in all, the oldest K882609 (1989). 76 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1989: 1 other ancestor1998: 2 other ancestors1993: 1 other ancestor1990: 1 other ancestor1997: 1 other ancestor1996: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor1992: 1 other ancestor2007: 2 descendants cleared2005: 2 descendants cleared2010: 4 descendants cleared2009: 2 descendants cleared2006: 1 descendant cleared2015: 2 descendants cleared2018: 7 descendants cleared2017: 2 descendants cleared2016: 1 descendant cleared2011: 3 descendants cleared2014: 3 descendants cleared2019: 4 descendants cleared2025: 12 descendants cleared2020: 7 descendants cleared2026: 4 descendants cleared2013: 2 descendants cleared2024: 7 descendants cleared2022: 5 descendants cleared2023: 4 descendants cleared2021: 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) K032979 · Philips SPO2 Reusable Sensors, Model Nos. M1191T, M1192T, and M1193T · Philips Medical Systems, Inc. · 20041990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 4 other ancestors3 generations back: 1 other ancestor4 generations back: 4 other ancestors 1 generation forward: 4 descendants2 generations forward: 9 descendants3 generations forward: 17 descendants4 generations forward: 9 descendants5 generations forward: 3 descendants6 generations forward: 5 descendants7 generations forward: 5 descendants8 generations forward: 4 descendants9 generations forward: 4 descendants10 generations forward: 5 descendants11 generations forward: 5 descendants12 generations forward: 6 descendants K032979 · Philips SPO2 Reusable Sensors, Model Nos. M1191T, M1192T, and M1193T · Philips Medical Systems, Inc. · 2004K990972 · 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 · 6 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 5 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
  3. 4 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
  4. 3 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
  5. 2 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  6. 1 generation backK032979 Philips SPO2 Reusable Sensors, Model Nos. M1191T, M1192T, and M1193TPhilips Medical Systems, Inc. · 2004
  7. This deviceK042306 Philips SP02 Disposable Sensor, Model M1131APhilips Medizin Systeme Boeblingen GmbH · 2004
  8. Descendant · cites it directly · 42 of its ownK052377 Philips Disposable SPO2 Sensors MII32A and M1133A.Philips Medizin Systeme Boeblingen GmbH · 2005
  9. Descendant · cites it directly · 41 of its ownK063783 Philips Reusable SPO2 Sensors M1191T, M1192T and M1193T, Clip Sensor…Philips Medical Systems, Inc. · 2007
  10. Descendant · 2 generations on · 38 of its ownK091572 Disposable SPO2 Sensor M1134APhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009
  11. Descendant · 3 generations on · 37 of its ownK101600 Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
  12. Descendant · 4 generations on · 36 of its ownK111905 Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011

Showing 5 of 76 descendants. See all descendants

Descendants cleared per year

2005: 22006: 12007: 22009: 22010: 42011: 32013: 22014: 32015: 22016: 12017: 22018: 72019: 42020: 72021: 22022: 52023: 42024: 72025: 122026: 4
2005high 12 (2025) · low 0 (2008)2026

Most influential descendants

Showing 5 of 76 · See all
  • K052377Philips Disposable SPO2 Sensors MII32A and M1133A.Philips Medizin Systeme Boeblingen GmbH · 2005 · cites it directly42descendants
  • K063783Philips Reusable SPO2 Sensors M1191T, M1192T and M1193T, Clip Sensor M1196T and…Philips Medical Systems, Inc. · 2007 · cites it directly41descendants
  • K091572Disposable SPO2 Sensor M1134APhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · 2 generations on38descendants
  • K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010 · 3 generations on37descendants
  • K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · 4 generations on36descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K941811HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co.1994—
−5K960934HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co.1996—
−4K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co.1999—
−3K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH1999—
−2K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
−1K032979Philips SPO2 Reusable Sensors, Model Nos. M1191T, M1192T, and M1193TPhilips Medical Systems, Inc.2004—
0 (this device)K042306Philips SP02 Disposable Sensor, Model M1131APhilips Medizin Systeme Boeblingen GmbH2004—
+1K052377Philips Disposable SPO2 Sensors MII32A and M1133A.Philips Medizin Systeme Boeblingen GmbH2005—
+1K063783Philips Reusable SPO2 Sensors M1191T, M1192T and M1193T, Clip Sensor M1196T…Philips Medical Systems, Inc.2007—
+2K091572Disposable SPO2 Sensor M1134APhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2009—
+3K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010—
+4K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199010
199210
199310
199410
199510
199610
199710
199820
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200520
200610
200720
200920
201040
201130
201320
201430
201520
201610
201720
201870
201940
202070
202120
202250
202340
202470
2025120
202640
FIG. 1 — Lineage of K042306, 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? (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
*K882609Models M1175A & M1176A Component Monitoring System
Summary page 2
…Oxisensor IITN D-20)and M1904B (Nellcor/Tyco Oxisensor IITM D-25) disposable SPO2 sensors cleared pursuant to K882609, 1/19/89; K990972, 4/19/99, K000822, 4/6/00, and K032979/S2, 2/20/04. Device The Philips Sp02 d…
Waltham Div. Hewlett Packard1989—
*K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…
Summary page 2
…0)and M1904B (Nellcor/Tyco Oxisensor IITM D-25) disposable SPO2 sensors cleared pursuant to K882609, 1/19/89; K990972, 4/19/99, K000822, 4/6/00, and K032979/S2, 2/20/04. Device The Philips Sp02 devices measure, no…
Hewlett-Packard GmbH1999—
*K000822Agilentcomponent Monitoring System, Agilent 24/26, Agilent Multi-Measurement Server and…
Summary page 2
…M1904B (Nellcor/Tyco Oxisensor IITM D-25) disposable SPO2 sensors cleared pursuant to K882609, 1/19/89; K990972, 4/19/99, K000822, 4/6/00, and K032979/S2, 2/20/04. Device The Philips Sp02 devices measure, non- Description…
Agilent Technologies, GmbH2000—
*K032979Philips SPO2 Reusable Sensors, Model Nos. M1191T, M1192T, and M1193T
Summary page 2
…TM D-25) disposable SPO2 sensors cleared pursuant to K882609, 1/19/89; K990972, 4/19/99, K000822, 4/6/00, and K032979/S2, 2/20/04. Device The Philips Sp02 devices measure, non- Description invasively, the arterial oxygen satu…
Philips Medical Systems, Inc.2004—

Also cleared against K882609: 7 other devices →

What descends from it? (76)

See all 76

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

NumberDeviceApplicantDecidedDescendants
K052377Philips Disposable SPO2 Sensors MII32A and M1133A.Philips Medizin Systeme Boeblingen GmbH200542
K063783Philips Reusable SPO2 Sensors M1191T, M1192T and M1193T, Clip Sensor M1196T and…Philips Medical Systems, Inc.200741
K100077Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103Solaris Medical Technology, Inc.201022
K052795Philips Avalon Fetal Monitor, Models FM20 and FM30Philips Medizin Systeme Boeblingen GmbH20059

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 10 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
  • None of the 17 ancestors has a recall.
  • Of its descendants, K052377 (Philips Medizin Systeme Boeblingen GmbH, 2005) has gone furthest, with 42 descendants of its own.
  • 7 other devices also cite its predicate K882609.

How does its category compare?

All DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

The Philips disposable Sp0 2 Sensor is intended for non-invasive measurement of oxygen saturation (SpO2) and pulse rate.

Indicated for adult/pediatric patients.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

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
  • K032979Philips SPO2 Reusable Sensors, Model Nos. M1191T, M1192T, and M1193TPhilips Medical Systems, Inc. · 2004
  • K033444Philips Medical Systems, M3012A- Hemodynamic Extension to the Multi-Measurement ServerPhilips Medical Systems · 2003
  • 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 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/K042306 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042306: Philips SP02 Disposable Sensor, Model M1131A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042306

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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