510(k) · Cleared
ClearedPhilips Adult Reusable SP02 Sensor, Model M1191B, M1191BL, M1191BNL
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 3, 2006 as substantially equivalent to K030973 (Philips Medical Systems, 2003) after a 72-day review. Its family tree reaches back 8 generations to 1994.
- Decided
- Nov 3, 2006
- Review
- 72 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K941811 (1994). 38 ancestors in all, the oldest K872781 (1987). No later device cites it as a predicate yet.
- 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 deviceK062455 Philips Adult Reusable SP02 Sensor, Model M1191B, M1191BL, M1191BNLPhilips Medical Systems · 2006
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) | K062455 | Philips Adult Reusable SP02 Sensor, Model M1191B, M1191BL, M1191BNL | Philips Medical Systems | 2006 | — |
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 |
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? (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; 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…21 C.FR §870.2700 Predicate Device Philips Medical System Adult SpO2 sensor, model ItMl 191IA Cleared for marketing via FD&C Act §5 10(k)# K882609, K990972, K000822 and K030973. Modifications The modification involves changes to the exterior cuf… | 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…FR §870.2700 Predicate Device Philips Medical System Adult SpO2 sensor, model ItMl 191IA Cleared for marketing via FD&C Act §5 10(k)# K882609, K990972, K000822 and K030973. Modifications The modification involves changes to the exterior cuff materia… | 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 ItMl 191IA Cleared for marketing via FD&C Act §5 10(k)# K882609, K990972, K000822 and K030973. Modifications The modification involves changes to the exterior cuff materials to imp… | 2000 |
| * | K030973 | Picosat II SPO2 Pulse Oximetry ModuleSummary page 1…Medical System Adult SpO2 sensor, model ItMl 191IA Cleared for marketing via FD&C Act §5 10(k)# K882609, K990972, K000822 and K030973. Modifications The modification involves changes to the exterior cuff materials to improve quality… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 38 ancestors has a recall of any class.
- 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?
Philips reusable SpO2 sensors are for multi-patient use, when continuous non-invasive arterial oxygen saturation and pulse rate monitoring are required.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062455 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062455: Philips Adult Reusable SP02 Sensor, Model M1191B, M1191BL, M1191BNL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062455
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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