# K043357: Tosca 500 PCO2, SPO2 and Pulse Rate Monitoring System, Model 5202009

- Pathway: 510(k) (Traditional)
- Applicant: Linde Medical Sensors AG
- Decided: Mar 4, 2005 after 88 days
- Product code: LKD (Monitor, Carbon-Dioxide, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 868.2480
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K890299 (1989). 3 ancestors in all.
92 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)
- K032291: Tosca PCO2, SPO2 and Pulse Rate Monitoring System, Linde Medical Sensors AG (2004) Summary page 1.

## Most influential descendants
- 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
- K120366: Intellivue Patient Monitor (2012), 46 descendants of its own

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

Source page: https://510kreport.com/device/K043357
Methodology: https://510kreport.com/methodology