510(k) · Cleared

Cleared

Philips Reusable SPO2 Sensors M1191T, M1192T and M1193T, Clip Sensor M1196T and Disposable SPO2 Sensors M1131A, M1132A

K063783510(k) SpecialCleared Apr 27, 2007127-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 Medical Systems, Inc. · DQA Oximeter

Cleared on Apr 27, 2007 as substantially equivalent to K032979 (Philips Medical Systems, Inc., 2004) and 3 other predicates after a 127-day review. Its family tree reaches back 9 generations to 1994. 41 later devices descend from it.

Decided: Apr 27, 2007
Review: 127 days
Class: Class II
Product code: DQA
Recalls: None
Predicates: 4

Its longest line of descent runs back 9 generations to K941811 (1994). 42 ancestors in all, the oldest K872781 (1987). 41 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 9 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
5 generations between
3 generations backK021300 Modification of Philips Component Compact Monitor, Release a.03…Philips Medical Systems · 2002
2 generations backK030973 Picosat II SPO2 Pulse Oximetry ModulePhilips Medical Systems · 2003
1 generation backK062605 Philips SPO2 Reusable Sensor, Models M1196A and M1196TPhilips Medical Systems · 2006
This deviceK063783 Philips Reusable SPO2 Sensors M1191T, M1192T and M1193T, Clip Sensor…Philips Medical Systems, Inc. · 2007
Descendant · cites it directly · 38 of its ownK091572 Disposable SPO2 Sensor M1134APhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009
Descendant · 2 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 · 3 generations on · 36 of its ownK111905 Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011
Descendant · 4 generations on · 35 of its ownK122223 New: Intellivue CL Respiration Pod New: Specialized Assessory…Philips Medizin Systeme Boeblingen GmbH · 2013
Descendant · 5 generations on · 24 of its ownK151736 Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH · 2015

Show all 9 generations

Root · 9 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
8 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
7 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
6 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
5 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
4 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
3 generations backK021300 Modification of Philips Component Compact Monitor, Release a.03…Philips Medical Systems · 2002
2 generations backK030973 Picosat II SPO2 Pulse Oximetry ModulePhilips Medical Systems · 2003
1 generation backK062605 Philips SPO2 Reusable Sensor, Models M1196A and M1196TPhilips Medical Systems · 2006
This deviceK063783 Philips Reusable SPO2 Sensors M1191T, M1192T and M1193T, Clip Sensor…Philips Medical Systems, Inc. · 2007

Showing 5 of 41 descendants. See all descendants

Descendants cleared per year

2009high 6 (2024) · low 0 (2012)2026

Most influential descendants

Showing 5 of 41 · See all

K091572Disposable SPO2 Sensor M1134APhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · cites it directly38descendants
K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010 · 2 generations on37descendants
K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · 3 generations on36descendants
K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH · 2013 · 4 generations on35descendants
K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH · 2015 · 5 generations on24descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−9	K941811	HP M1175A, M1176A, Component Monitoring System	Hewlett-Packard Co.	1994	—
−8	K960934	HP M1205A Omnicare Component Monitor System Model 24	Hewlett-Packard Co.	1996	—
−7	K981376	Hewlett-Packard M1205A Viridia 24 CT	Hewlett-Packard Co.	1999	—
−6	K990125	HP Viridia Component Monitoring System, Model Rev. K	Hewlett-Packard GmbH	1999	—
−5	K990972	HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…	Hewlett-Packard GmbH	1999	—
−4	K013199	Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…	Philips Medical Systems, Inc.	2001	—
−3	K021300	Modification of Philips Component Compact Monitor, Release a.03, Model M1275B	Philips Medical Systems	2002	—
−2	K030973	Picosat II SPO2 Pulse Oximetry Module	Philips Medical Systems	2003	—
−1	K062605	Philips SPO2 Reusable Sensor, Models M1196A and M1196T	Philips Medical Systems	2006	—
0 (this device)	K063783	Philips Reusable SPO2 Sensors M1191T, M1192T and M1193T, Clip Sensor M1196T…	Philips Medical Systems, Inc.	2007	—
+1	K091572	Disposable SPO2 Sensor M1134A	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2009	—
+2	K101600	Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2010	—
+3	K111905	Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2011	—
+4	K122223	New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp…	Philips Medizin Systeme Boeblingen GmbH	2013	—
+5	K151736	Philips IntelliVue GuardianSoftware	Philips Medizin Systeme Boblingen GmbH	2015	—

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
2009	2	0
2010	1	0
2011	1	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	6	0
2026	2	0

FIG. 1 — Lineage of K063783, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K032979	Philips SPO2 Reusable Sensors, Model Nos. M1191T, M1192T, and M1193T Summary page 1 …r 2. The new device is substantially equivalent to previously cleared Philips devices Philips Reusable Spo2 Sensors M1191T, M1192T, & M1193T marketed pursuant to K032979; Philips SpO2 Reusable Clip Sensor M1196T pursuant to K062605; Philips Disposable SP0 2 Sensor M1131A pursuant to K042306;…	Philips Medical Systems, Inc.	2004	—
*	K062605	Philips SPO2 Reusable Sensor, Models M1196A and M1196T Summary page 1 …leared Philips devices Philips Reusable Spo2 Sensors M1191T, M1192T, & M1193T marketed pursuant to K032979; Philips SpO2 Reusable Clip Sensor M1196T pursuant to K062605; Philips Disposable SP0 2 Sensor M1131A pursuant to K042306; as well as Philips Disposable SP02 Sensors M1132A & M1133A pur…	Philips Medical Systems	2006	—
*	K042306	Philips SP02 Disposable Sensor, Model M1131A Summary page 1 …M1192T, & M1193T marketed pursuant to K032979; Philips SpO2 Reusable Clip Sensor M1196T pursuant to K062605; Philips Disposable SP0 2 Sensor M1131A pursuant to K042306; as well as Philips Disposable SP02 Sensors M1132A & M1133A pursuant to K052377. 3. The modification involves a labeling chan…	Philips Medizin Systeme Boeblingen GmbH	2004	—
*	K052377	Philips Disposable SPO2 Sensors MII32A and M1133A. Summary page 1 …nsor M1196T pursuant to K062605; Philips Disposable SP0 2 Sensor M1131A pursuant to K042306; as well as Philips Disposable SP02 Sensors M1132A & M1133A pursuant to K052377. 3. The modification involves a labeling change to add compatibility of the subject sensors with three existing non-Philips m…	Philips Medizin Systeme Boeblingen GmbH	2005	—

Also cleared against K032979: 4 other devices →

What descends from it? (41)

See all 41

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

Number	Device	Applicant	Decided	Descendants
K091572	Disposable SPO2 Sensor M1134A	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2009	38
K092549	Oxiprobe, Models BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P	Bio Medical Technologies Co., Ltd.	2009	1

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 13 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
1 of the 42 ancestors has a recall of any class.
Of its descendants, K091572 (Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, 2009) has gone furthest, with 38 descendants of its own.
4 other devices also cite its predicate K032979.

How does its category compare?

All DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · DQA

15in 2025

2007high 35 (2009) · low 9 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQA

182in 2025

2007high 317 (2023) · low 97 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQA

3in 2024

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

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

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 and disposable SpO2 Sensors are intended for non-invasive measurement of oxygen saturation (SpO2) and pulse rate.

Philips Reusable SP02 Sensors M1191T, M1192T, and M1193T

M1191T is indicated for adult patients, M1192T is indicated for pediatric patients, and M1193T is indicated for neonatal patients.

Philips SPO2 Reusable Clip Sensors Models M1196T

M1196T is indicated for patients > 40 kg (typically adult patients)

Philips Disposable SP02 Sensor M1131A

M1131A is indicated for adult patients/pediatric patients

Philips Disposable SpO2 Sensors M1132A and M1133A

M1132A is indicated for infant patients, and M1133A for adult/infant/neonatal patients.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063783 · printed Nov 6, 2026

Cite this page

510(k) Report. “K063783: Philips Reusable SPO2 Sensors M1191T, M1192T and M1193T, Clip Sensor M1196T and Disposable SPO2 Sensors M1131A, M1132A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063783

Report an extraction error

Are you the manufacturer?

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