# K062268: Masimo Set SPO2 Module for Philips and M3001A Multi-Measurement Server Option A03

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems North America Co.
- Decided: Oct 18, 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: 13 generations back to K941811 (1994). 63 ancestors in all.
38 later devices descend from it; 1 cites it directly.
0 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013199: Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276B, Philips Medical Systems, Inc. (2001) Summary page 1.
- K020531: Philips Multi-Parameter Module, Model M3001A; Philips Component Compact Monitor, Release a.02, Model M1275B, Philips Medical Systems (2002) Summary page 1.
- K030973: Picosat II SPO2 Pulse Oximetry Module, Philips Medical Systems (2003) Summary page 1.
- K040259: Masimo Set Intellivue Pulse Oximeter Module, Masimo Corp. (2004) Summary page 1.
- K053269: Masimo Set Rad-8 Pulse Oximeter, Masimo Corporation (2005) Summary page 1.
- K051439: Lnop Blue Oximetry Sensor, Masimo Corporation (2005) 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
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in patient transport and healthcare environments.

Source page: https://510kreport.com/device/K062268
Methodology: https://510kreport.com/methodology