# K003943: Microgas 7650 Transcutaneous Monitor

- Pathway: 510(k) (Special)
- Applicant: Linde Medical Sensors AG
- Decided: May 4, 2001 after 134 days
- Product code: KLK (Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.2500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
94 later devices descend from it; 2 cite it directly.
0 of 95 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K032291: Tosca PCO2, SPO2 and Pulse Rate Monitoring System (2004), 93 descendants of its own
- 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

Source page: https://510kreport.com/device/K003943
Methodology: https://510kreport.com/methodology