510(k) · Cleared
ClearedPhilips SPO2 Reusable Sensor, Models M1196A and M1196T
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems · DQA Oximeter
Cleared on Nov 9, 2006 as substantially equivalent to K030973 (Philips Medical Systems, 2003) and 1 other predicate after a 65-day review. Its family tree reaches back 8 generations to 1994. 46 later devices descend from it.
- Decided
- Nov 9, 2006
- Review
- 65 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K941811 (1994). 39 ancestors in all, the oldest K872781 (1987). 46 later devices descend from it, 5 citing it directly.
- Root · 8 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 7 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 6 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 5 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 4 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 3 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 2 generations backK021300 Modification of Philips Component Compact Monitor, Release a.03…Philips Medical Systems · 2002
- 1 generation backK030973 Picosat II SPO2 Pulse Oximetry ModulePhilips Medical Systems · 2003
- This deviceK062605 Philips SPO2 Reusable Sensor, Models M1196A and M1196TPhilips Medical Systems · 2006
- Descendant · cites it directly · 41 of its ownK063783 Philips Reusable SPO2 Sensors M1191T, M1192T and M1193T, Clip Sensor…Philips Medical Systems, Inc. · 2007
- Descendant · 2 generations on · 38 of its ownK091572 Disposable SPO2 Sensor M1134APhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009
- 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
- Descendant · 4 generations on · 36 of its ownK111905 Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011
- Descendant · 5 generations on · 35 of its ownK122223 New: Intellivue CL Respiration Pod New: Specialized Assessory…Philips Medizin Systeme Boeblingen GmbH · 2013
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- 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
- K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH · 2013 · 5 generations on35descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −7 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −6 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −5 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −4 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −3 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −2 | K021300 | Modification of Philips Component Compact Monitor, Release a.03, Model M1275B | Philips Medical Systems | 2002 | — |
| −1 | K030973 | Picosat II SPO2 Pulse Oximetry Module | Philips Medical Systems | 2003 | — |
| 0 (this device) | 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 | — |
| +2 | K091572 | Disposable SPO2 Sensor M1134A | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2009 | — |
| +3 | K101600 | Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2010 | — |
| +4 | K111905 | Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011 | — |
| +5 | K122223 | New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp… | Philips Medizin Systeme Boeblingen GmbH | 2013 | — |
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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 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 | 7 | 0 |
| 2026 | 3 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K882609 | FDA’s K882609 is Models M1175A & M1176A Component Monitoring System Our reading of the summary gave K882609, FDA’s number for Models M1175A & M1176A Component Monitoring System (Waltham Div. Hewlett Packard). Its FDA name has none of the distinctive words the summary uses for the device it names, “Philips Medical System Adult SpO2 sensor, model # M1191A”. Kept off the family tree. Summary page 1…C.F.R §870.2700 Predicate Device Philips Medical System Adult SpO2 sensor, model # Ml 191A Cleared for marketing via FD&C Act §510(k)# K882609, K990972, K000822, K030973 and K032979. Modifications The modification involves a change fro… | 1989 |
| Kept off the family tree | K990972 | FDA’s K990972 is HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… Our reading of the summary gave K990972, FDA’s number for HP Viridia Component Monitoring System, HP Viridia CMS… (Hewlett-Packard GmbH). Its FDA name has none of the distinctive words the summary uses for the device it names, “Philips Medical System Adult SpO2 sensor, model # M1191A”. Kept off the family tree. Summary page 1…70.2700 Predicate Device Philips Medical System Adult SpO2 sensor, model # Ml 191A Cleared for marketing via FD&C Act §510(k)# K882609, K990972, K000822, K030973 and K032979. Modifications The modification involves a change from a soft… | 1999 |
| Kept off the family tree | K000822 | FDA’s K000822 is Agilentcomponent Monitoring System, Agilent 24/26, Agilent Multi-Measurement… Our reading of the summary gave K000822, FDA’s number for Agilentcomponent Monitoring System, Agilent 24/26, Agilent… (Agilent Technologies, GmbH). Its FDA name has none of the distinctive words the summary uses for the device it names, “Philips Medical System Adult SpO2 sensor, model # M1191A”. Kept off the family tree. Summary page 1…Philips Medical System Adult SpO2 sensor, model # Ml 191A Cleared for marketing via FD&C Act §510(k)# K882609, K990972, K000822, K030973 and K032979. Modifications The modification involves a change from a soft cuff style to a clip… | 2000 |
| * | K030973 | Picosat II SPO2 Pulse Oximetry ModuleSummary page 1…edical System Adult SpO2 sensor, model # Ml 191A Cleared for marketing via FD&C Act §510(k)# K882609, K990972, K000822, K030973 and K032979. Modifications The modification involves a change from a soft cuff style to a clip… | 2003 |
| * | K032979 | Philips SPO2 Reusable Sensors, Model Nos. M1191T, M1192T, and M1193TSummary page 1…m Adult SpO2 sensor, model # Ml 191A Cleared for marketing via FD&C Act §510(k)# K882609, K990972, K000822, K030973 and K032979. Modifications The modification involves a change from a soft cuff style to a clip style hou… | 2004 |
What descends from it? (46)
See all 465 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063783 | Philips Reusable SPO2 Sensors M1191T, M1192T and M1193T, Clip Sensor M1196T and… | 2007 | 41 |
| K252821 | Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m)… | 2026 | 0 |
| K243086 | Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable… | 2025 | 0 |
| K103584 | Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda Compatible Disposable and… | 2011 | 0 |
| K090438 | Reusable Envitec Finger SPO2 Sensor-HP/Philips Compatible, Models F-2412, F-2414-15… | 2009 | 0 |
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 12 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 39 ancestors has a recall of any class.
- Of its descendants, K063783 (Philips Medical Systems, Inc., 2007) has gone furthest, with 41 descendants of its own.
- 9 other devices also cite its predicate K030973.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 M1196A and M1196T reusable Clip sensors provide
continuous, non-invasive measurement of arterial oxygen
saturation (pulse rate signal and plethysmograph wave) to
any SpO2 device that has passed validation testing. Either
sensor can be comfortably clipped onto the finger of patients
weighing > 40 kg (typically adult patients).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062605 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062605: Philips SPO2 Reusable Sensor, Models M1196A and M1196T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062605
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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