# K062605: Philips SPO2 Reusable Sensor, Models M1196A and M1196T

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems
- Decided: Nov 9, 2006 after 65 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K941811 (1994). 39 ancestors in all.
46 later devices descend from it; 5 cite it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030973: Picosat II SPO2 Pulse Oximetry Module, Philips Medical Systems (2003) Summary page 1.
- K032979: Philips SPO2 Reusable Sensors, Model Nos. M1191T, M1192T, and M1193T, Philips Medical Systems, Inc. (2004) Summary page 1.

## Cited in the summary but kept off the family tree
- K882609: Models M1175A & M1176A Component Monitoring System, Waltham Div. Hewlett Packard (1989). 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.
- K990972: HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia Multi-Measurement Server and Compact Portable T, Hewlett-Packard GmbH (1999). 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.
- K000822: Agilentcomponent Monitoring System, Agilent 24/26, Agilent Multi-Measurement Server and Compact Portable Patient Monitor, Agilent Technologies, GmbH (2000). 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.

## Most influential descendants
- K063783: Philips Reusable SPO2 Sensors M1191T, M1192T and M1193T, Clip Sensor M1196T and Disposable SPO2 Sensors M1131A, M1132A (2007), 41 descendants of its own
- K091572: Disposable SPO2 Sensor M1134A (2009), 38 descendants of its own
- K101600: Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue Patient Monitors MP5, MP2, X2 Model (2010), 37 descendants of its own
- K111905: Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216 (2011), 36 descendants of its own
- K122223: New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment Modified: Intellivue Patient MO (2013), 35 descendants of its own

## Indications for use
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).

Source page: https://510kreport.com/device/K062605
Methodology: https://510kreport.com/methodology