# K062455: Philips Adult Reusable SP02 Sensor, Model M1191B, M1191BL, M1191BNL

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems
- Decided: Nov 3, 2006 after 72 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). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 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.

## 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.

## Indications for use
Philips reusable SpO2 sensors are for multi-patient use, when continuous non-invasive arterial oxygen saturation and pulse rate monitoring are required.

Source page: https://510kreport.com/device/K062455
Methodology: https://510kreport.com/methodology