# K081937: Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2  Pulse Oximetry Module

- Pathway: 510(k) (Special)
- Applicant: Philips Medizin Systeme Boeblingen GmbH
- Decided: Aug 29, 2008 after 53 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: 27 generations back to K941811 (1994). 172 ancestors in all.
49 later devices descend from it; 3 cite it directly.
0 of 222 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033715: Picosat II SP02 Pulse Oximetry Module and M3001A Multi-Measurement Server, Philips Medical Systems, Inc. (2004) Summary page 1.
- K021300: Modification of Philips Component Compact Monitor, Release a.03, Model M1275B, Philips Medical Systems (2002) Summary page 1.
- K072070: Philips MP2 and X2 Intellivue Patient Monitors, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (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
Indicated for use whenever there is a need for monitoring, transport monitoring, recording, and alarming of the physiological parameters arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric and neonatal patients in a hospital environment by health care professionals. X2 (M3002A) Multi-Measurement Module is indicated for transport monitoring outside hospitals.

Source page: https://510kreport.com/device/K081937
Methodology: https://510kreport.com/methodology