# K063783: Philips Reusable SPO2 Sensors M1191T, M1192T and M1193T, Clip Sensor M1196T and Disposable SPO2 Sensors M1131A, M1132A

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems, Inc.
- Decided: Apr 27, 2007 after 127 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). 42 ancestors in all.
41 later devices descend from it; 2 cite it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032979: Philips SPO2 Reusable Sensors, Model Nos. M1191T, M1192T, and M1193T, Philips Medical Systems, Inc. (2004) Summary page 1.
- K062605: Philips SPO2 Reusable Sensor, Models M1196A and M1196T, Philips Medical Systems (2006) Summary page 1.
- K042306: Philips SP02 Disposable Sensor, Model M1131A, Philips Medizin Systeme Boeblingen GmbH (2004) Summary page 1.
- K052377: Philips Disposable SPO2 Sensors MII32A and M1133A., Philips Medizin Systeme Boeblingen GmbH (2005) Summary page 1.

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

## Indications for use
The Philips reusable and disposable SpO2 Sensors are intended for non-invasive measurement of oxygen saturation (SpO2) and pulse rate. Philips Reusable SP02 Sensors M1191T, M1192T, and M1193T M1191T is indicated for adult patients, M1192T is indicated for pediatric patients, and M1193T is indicated for neonatal patients. Philips SPO2 Reusable Clip Sensors Models M1196T M1196T is indicated for patients > 40 kg (typically adult patients) Philips Disposable SP02 Sensor M1131A M1131A is indicated for adult patients/pediatric patients Philips Disposable SpO2 Sensors M1132A and M1133A M1132A is indicated for infant patients, and M1133A for adult/infant/neonatal patients.

Source page: https://510kreport.com/device/K063783
Methodology: https://510kreport.com/methodology