# K030973: Picosat II SPO2 Pulse Oximetry Module

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems
- Decided: Jul 23, 2003 after 117 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: 7 generations back to K941811 (1994). 37 ancestors in all.
198 later devices descend from it; 10 cite it directly.
0 of 236 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971910: Multi-Parameter Module (M3000A)/Display Unit (M3046A), Hewlett-Packard GmbH (1998) Summary page 1.
- 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 1.
- K013199: Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276B, Philips Medical Systems, Inc. (2001) Summary page 1.
- K021300: Modification of Philips Component Compact Monitor, Release a.03, Model M1275B, Philips Medical Systems (2002) Summary page 1.

## Cited in the summary but kept off the family tree
- K000822: Agilentcomponent Monitoring System, Agilent 24/26, Agilent Multi-Measurement Server and Compact Portable Patient Monitor, Agilent Technologies, GmbH (2000). Our reading of the summary gave K000822, FDA’s number for Agilentcomponent Monitoring System, Agilent 24/26, Agilent… (Agilent Technologies, GmbH). Its FDA name has none of the distinctive words the summary uses for the device it names, “M3000A & M3001A”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K033715: Picosat II SP02 Pulse Oximetry Module and M3001A Multi-Measurement Server (2004), 186 descendants of its own
- K062392: Philips MP5 Intellivue Patient Monitor (2006), 176 descendants of its own
- K063725: MP5 Intellivue Patient Monitor (2007), 175 descendants of its own
- K071426: MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90  Intellivue Patient Monitors (2007), 151 descendants of its own
- K081793: Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry System Transceiver (2008), 143 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 hospital environments.

Source page: https://510kreport.com/device/K030973
Methodology: https://510kreport.com/methodology