# K063434: Tosca 500 TCPCO2,  SPO2 and Pulse Rate Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Radiometer Basel AG
- Decided: Jan 22, 2007 after 70 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: 3 generations back to K890299 (1989). 4 ancestors in all.
91 later devices descend from it; 3 cite it directly.
0 of 96 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043357: Tosca 500 PCO2, SPO2 and Pulse Rate Monitoring System, Model 5202009, Linde Medical Sensors AG (2005) Summary page 1.

## Most influential descendants
- K093154: TCM Tosca Monitoring System, TCM Combim Monitoring System (2010), 87 descendants of its own
- K110474: Philips Intellivue TCG10 (2011), 84 descendants of its own
- K113441: Physiological Monitor, Patient Monitor (2012), 78 descendants of its own
- K120366: Intellivue Patient Monitor (2012), 46 descendants of its own
- K122439: Intellivue Patient Monitor (2012), 41 descendants of its own

## Indications for use
The TOSCA 500 Monitoring System is designed for the simultaneous continuous monitoring of transcutaneous PCO 2, functional oxygen saturation SPO2 and Pulse Rate in adults and pediatrics.

Source page: https://510kreport.com/device/K063434
Methodology: https://510kreport.com/methodology