# K032291: Tosca PCO2, SPO2 and Pulse Rate Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Linde Medical Sensors AG
- Decided: Aug 24, 2004 after 397 days
- Product code: DOA (Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.)
- Device class: 2
- Regulation: 21 CFR 862.3320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K890299 (1989). 2 ancestors in all.
93 later devices descend from it; 1 cites 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)
- K003943: Microgas 7650 Transcutaneous Monitor, Linde Medical Sensors AG (2001) Summary page 1.
- K890299: Kontron Pulse Oximeter 7840, Kontron Instruments, Inc. (1989) Summary page 1.

## Most influential descendants
- K043357: Tosca 500 PCO2, SPO2 and Pulse Rate Monitoring System, Model 5202009 (2005), 92 descendants of its own
- K063434: Tosca 500 TCPCO2,  SPO2 and Pulse Rate Monitoring System (2007), 91 descendants of its own
- 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

## Indications for use
The Linde TOSCA 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/K032291
Methodology: https://510kreport.com/methodology