510(k) · Cleared
ClearedPhilips SPO2 Reusable Sensors, Model Nos. M1191T, M1192T, and M1193T
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems, Inc. · DQA Oximeter
Cleared on Feb 20, 2004 as substantially equivalent to K882609 (Waltham Div. Hewlett Packard, 1989) and 2 other predicates after a 149-day review. Its family tree reaches back 5 generations to 1994. 88 later devices descend from it.
- Decided
- Feb 20, 2004
- Review
- 149 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K941811 (1994). 16 ancestors in all, the oldest K882609 (1989). 88 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 4 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 3 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 2 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 1 generation backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- This deviceK032979 Philips SPO2 Reusable Sensors, Model Nos. M1191T, M1192T, and M1193TPhilips Medical Systems, Inc. · 2004
- Descendant · cites it directly · 76 of its ownK042306 Philips SP02 Disposable Sensor, Model M1131APhilips Medizin Systeme Boeblingen GmbH · 2004
- Descendant · cites it directly · 46 of its ownK062605 Philips SPO2 Reusable Sensor, Models M1196A and M1196TPhilips Medical Systems · 2006
- Descendant · 2 generations on · 42 of its ownK052377 Philips Disposable SPO2 Sensors MII32A and M1133A.Philips Medizin Systeme Boeblingen GmbH · 2005
- 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
Showing 5 of 88 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 88 · See all- K042306Philips SP02 Disposable Sensor, Model M1131APhilips Medizin Systeme Boeblingen GmbH · 2004 · cites it directly76descendants
- K062605Philips SPO2 Reusable Sensor, Models M1196A and M1196TPhilips Medical Systems · 2006 · cites it directly46descendants
- K052377Philips Disposable SPO2 Sensors MII32A and M1133A.Philips Medizin Systeme Boeblingen GmbH · 2005 · 2 generations on42descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −4 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −3 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −2 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −1 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| 0 (this device) | K032979 | Philips SPO2 Reusable Sensors, Model Nos. M1191T, M1192T, and M1193T | Philips Medical Systems, Inc. | 2004 | — |
| +1 | K042306 | Philips SP02 Disposable Sensor, Model M1131A | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| +1 | K062605 | Philips SPO2 Reusable Sensor, Models M1196A and M1196T | Philips Medical Systems | 2006 | — |
| +2 | K052377 | Philips Disposable SPO2 Sensors MII32A and M1133A. | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 0 |
| 2011 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 7 | 0 |
| 2019 | 4 | 0 |
| 2020 | 7 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2023 | 4 | 0 |
| 2024 | 8 | 0 |
| 2025 | 13 | 0 |
| 2026 | 5 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K882609 | Models M1175A & M1176A Component Monitoring SystemSummary page 1…(Nellcor/Tyco Oxisensor IITm D- 20)and M1904B (Nellcor/Tyco Oxisensor IITm D-25)disposable SP02 sensors cleared pursuant to K882609, 1/19/89; K990972, 4/19/99, and K000822, 4/6/00. Modifications The modification involves a chang… | 1989 |
| * | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Summary page 1…ensor IITm D- 20)and M1904B (Nellcor/Tyco Oxisensor IITm D-25)disposable SP02 sensors cleared pursuant to K882609, 1/19/89; K990972, 4/19/99, and K000822, 4/6/00. Modifications The modification involves a change to the connector… | 1999 |
| * | K000822 | Agilentcomponent Monitoring System, Agilent 24/26, Agilent Multi-Measurement Server and…Summary page 1…1904B (Nellcor/Tyco Oxisensor IITm D-25)disposable SP02 sensors cleared pursuant to K882609, 1/19/89; K990972, 4/19/99, and K000822, 4/6/00. Modifications The modification involves a change to the connector from the proprietary… | 2000 |
What descends from it? (88)
See all 885 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042306 | Philips SP02 Disposable Sensor, Model M1131A | 2004 | 76 |
| K062605 | Philips SPO2 Reusable Sensor, Models M1196A and M1196T | 2006 | 46 |
| K063783 | Philips Reusable SPO2 Sensors M1191T, M1192T and M1193T, Clip Sensor M1196T and… | 2007 | 41 |
| K052795 | Philips Avalon Fetal Monitor, Models FM20 and FM30 | 2005 | 9 |
| K043463 | Envitec Reusable Multi-Site Y SPO2 Sensors | 2005 | 5 |
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 3 companies; a new generation was cleared every 2.1 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K042306 (Philips Medizin Systeme Boeblingen GmbH, 2004) has gone furthest, with 76 descendants of its own.
- 7 other devices also cite its predicate K882609.
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 Philips Reusable SPO2 Sensors are intended for acquiring non-invasively the arterial oxygen saturation to support the measurement of oxygen saturation.
M1191T is indicated for adult patients, MI 192T is indicated for pediatric patients, and MI 193T is indicated for neonatal patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032979 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032979: Philips SPO2 Reusable Sensors, Model Nos. M1191T, M1192T, and M1193T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032979
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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