# K042306: Philips SP02 Disposable Sensor, Model M1131A

- Pathway: 510(k) (Abbreviated)
- Applicant: Philips Medizin Systeme Boeblingen GmbH
- Decided: Oct 15, 2004 after 51 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: 6 generations back to K941811 (1994). 17 ancestors in all.
76 later devices descend from it; 4 cite it directly.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K882609: Models M1175A & M1176A Component Monitoring System, Waltham Div. Hewlett Packard (1989) Summary page 2.
- K990972: HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia Multi-Measurement Server and Compact Portable T, Hewlett-Packard GmbH (1999) Summary page 2.
- K000822: Agilentcomponent Monitoring System, Agilent 24/26, Agilent Multi-Measurement Server and Compact Portable Patient Monitor, Agilent Technologies, GmbH (2000) Summary page 2.
- K032979: Philips SPO2 Reusable Sensors, Model Nos. M1191T, M1192T, and M1193T, Philips Medical Systems, Inc. (2004) Summary page 2.

## Most influential descendants
- K052377: Philips Disposable SPO2 Sensors MII32A and M1133A. (2005), 42 descendants of its own
- 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

## Indications for use
The Philips disposable Sp0 2 Sensor is intended for non-invasive measurement of oxygen saturation (SpO2) and pulse rate. Indicated for adult/pediatric patients.

Source page: https://510kreport.com/device/K042306
Methodology: https://510kreport.com/methodology