# K252821: Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medizin Systeme Böblingen GmbH
- Decided: May 29, 2026 after 267 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: 9 generations back to K941811 (1994). 40 ancestors in all.
No later device cites it as a predicate yet.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062605: Philips SPO2 Reusable Sensor, Models M1196A and M1196T, Philips Medical Systems (2006) Summary page 5.

## Indications for use
The Philips Reusable SpO2 Sensors are intended for non-invasive measurement of oxygen saturation (SpO2) and pulse rate. M1196A and M1196T are indicated for patients > 40 kg (typically adult patients).

Source page: https://510kreport.com/device/K252821
Methodology: https://510kreport.com/methodology