# K091572: Disposable SPO2 Sensor M1134A

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
- Decided: Sep 22, 2009 after 112 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: 10 generations back to K941811 (1994). 43 ancestors in all.
38 later devices descend from it; 1 cites it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052377: Philips Disposable SPO2 Sensors MII32A and M1133A., Philips Medizin Systeme Boeblingen GmbH (2005) Summary page 1.
- K063783: Philips Reusable SPO2 Sensors M1191T, M1192T and M1193T, Clip Sensor M1196T and Disposable SPO2 Sensors M1131A, M1132A, Philips Medical Systems, Inc. (2007) Summary page 1.

## Most influential descendants
- 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
- K151736: Philips IntelliVue GuardianSoftware (2015), 24 descendants of its own
- K161767: Philips IntelliVue GuardianSoftware (2017), 23 descendants of its own

## Indications for use
The Philips 'disposable SpO2 sensor M1134A is indicated for use by health care professionals whenever there is a need for acquiring non-invasively the arterial oxygen saturation to support the measurement of oxygen saturation. Intended for monitoring, recording, and alarming of the physiological parameters arterial oxygen saturation (SpO2) and pulse rate of adults, infants, and neonates in a healthcare environment and during transport inside and outside of healthcare environments.

Source page: https://510kreport.com/device/K091572
Methodology: https://510kreport.com/methodology