510(k) · Cleared
ClearedDisposable SPO2 Sensor M1134A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · DQA Oximeter
Cleared on Sep 22, 2009 as substantially equivalent to K052377 (Philips Medizin Systeme Boeblingen GmbH, 2005) and 1 other predicate after a 112-day review. Its family tree reaches back 10 generations to 1994. 38 later devices descend from it.
- Decided
- Sep 22, 2009
- Review
- 112 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K941811 (1994). 43 ancestors in all, the oldest K872781 (1987). 38 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 6 generations between
- 3 generations backK030973 Picosat II SPO2 Pulse Oximetry ModulePhilips Medical Systems · 2003
- 2 generations backK062605 Philips SPO2 Reusable Sensor, Models M1196A and M1196TPhilips Medical Systems · 2006
- 1 generation backK063783 Philips Reusable SPO2 Sensors M1191T, M1192T and M1193T, Clip Sensor…Philips Medical Systems, Inc. · 2007
- This deviceK091572 Disposable SPO2 Sensor M1134APhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009
- 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
- Descendant · 2 generations on · 36 of its ownK111905 Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011
- Descendant · 3 generations on · 35 of its ownK122223 New: Intellivue CL Respiration Pod New: Specialized Assessory…Philips Medizin Systeme Boeblingen GmbH · 2013
- Descendant · 4 generations on · 24 of its ownK151736 Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH · 2015
- Descendant · 5 generations on · 23 of its ownK161767 Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH · 2017
Show all 10 generations
- Root · 10 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 9 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 8 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 7 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 6 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 5 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 4 generations backK021300 Modification of Philips Component Compact Monitor, Release a.03…Philips Medical Systems · 2002
- 3 generations backK030973 Picosat II SPO2 Pulse Oximetry ModulePhilips Medical Systems · 2003
- 2 generations backK062605 Philips SPO2 Reusable Sensor, Models M1196A and M1196TPhilips Medical Systems · 2006
- 1 generation backK063783 Philips Reusable SPO2 Sensors M1191T, M1192T and M1193T, Clip Sensor…Philips Medical Systems, Inc. · 2007
- This deviceK091572 Disposable SPO2 Sensor M1134APhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −9 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −8 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −7 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −6 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −5 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −4 | K021300 | Modification of Philips Component Compact Monitor, Release a.03, Model M1275B | Philips Medical Systems | 2002 | — |
| −3 | K030973 | Picosat II SPO2 Pulse Oximetry Module | Philips Medical Systems | 2003 | — |
| −2 | K062605 | Philips SPO2 Reusable Sensor, Models M1196A and M1196T | Philips Medical Systems | 2006 | — |
| −1 | K063783 | Philips Reusable SPO2 Sensors M1191T, M1192T and M1193T, Clip Sensor M1196T… | Philips Medical Systems, Inc. | 2007 | — |
| 0 (this device) | K091572 | Disposable SPO2 Sensor M1134A | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2009 | — |
| +1 | K101600 | Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2010 | — |
| +2 | K111905 | Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011 | — |
| +3 | K122223 | New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp… | Philips Medizin Systeme Boeblingen GmbH | 2013 | — |
| +4 | K151736 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boblingen GmbH | 2015 | — |
| +5 | K161767 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boeblingen GmbH | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 8 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 6 | 0 |
| 2025 | 6 | 0 |
| 2026 | 2 | 0 |
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 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052377 | Philips Disposable SPO2 Sensors MII32A and M1133A.Summary page 1…Oximeter 74 3. The modified device is substantially equivalent to previously, cleared Philips disposable Sp0 2 sensor M1133A (K052377, K063783) The modified device uses adhesive-free material (adhesive-free skins) which covers the optical part… | 2005 |
| * | K063783 | Philips Reusable SPO2 Sensors M1191T, M1192T and M1193T, Clip Sensor M1196T and…Summary page 1…er 74 3. The modified device is substantially equivalent to previously, cleared Philips disposable Sp0 2 sensor M1133A (K052377, K063783) The modified device uses adhesive-free material (adhesive-free skins) which covers the optical parts of the… | 2007 |
What descends from it? (38)
See all 381 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101600 | Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue… | 2010 | 37 |
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 2.1 years on median.
- 1 of the 43 ancestors has 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.
- 1 other device also cites its predicate K052377.
How does its category compare?
All DQA devicesDQA 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
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 2025
MAUDE reports naming product code DQA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 20 | 122 | 6 | 325 |
| 2008 | 22 | 97 | 5 | 312 |
| 2009 | 35 | 117 | 29 | 281 |
| 2010 | 29 | 127 | 4 | 185 |
| 2011 | 15 | 195 | 1 | 164 |
| 2012 | 14 | 120 | 0 | 322 |
| 2013 | 15 | 182 | 0 | 468 |
| 2014 | 11 | 175 | 2 | 1,124 |
| 2015 | 13 | 158 | 1 | 2,082 |
| 2016 | 14 | 246 | 0 | 1,775 |
| 2017 | 9 | 200 | 0 | 1,190 |
| 2018 | 18 | 260 | 32 | 694 |
| 2019 | 19 | 158 | 0 | 548 |
| 2020 | 15 | 126 | 0 | 426 |
| 2021 | 10 | 174 | 0 | 553 |
| 2022 | 20 | 265 | 0 | 478 |
| 2023 | 13 | 317 | 0 | 392 |
| 2024 | 14 | 285 | 3 | 545 |
| 2025 | 15 | 182 | 0 | 399 |
| 2026 | 8 | 187 | 0 | — |
What is it indicated for?
The Philips 'disposable SpO2 sensor M1134A is indicated for use by health care professionals whenever there is a need for acquiring non-invasively the arterial oxygen saturation to support the measurement of oxygen saturation. Intended for monitoring, recording, and alarming of the physiological parameters arterial oxygen saturation (SpO2) and pulse rate of adults, infants, and neonates in a healthcare environment and during transport inside and outside of healthcare environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091572 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091572: Disposable SPO2 Sensor M1134A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091572
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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