# K093154: TCM Tosca Monitoring System, TCM Combim Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Radiometer Medical Aps
- Decided: Feb 5, 2010 after 122 days
- Product code: LKD (Monitor, Carbon-Dioxide, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 868.2480
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K890299 (1989). 6 ancestors in all.
87 later devices descend from it; 2 cite it directly.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063434: Tosca 500 TCPCO2,  SPO2 and Pulse Rate Monitoring System, Radiometer Basel AG (2007) Summary page 2.
- K003943: Microgas 7650 Transcutaneous Monitor, Linde Medical Sensors AG (2001) Summary page 2.
- K043003: TCM40 Monitoring System, Radiometer Medical Aps (2005) Summary page 2.

## Most influential descendants
- 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
- K131872: Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550 (2013), 37 descendants of its own

## Recalls of this device
- Feb 20, 2020 · Class II · Z-1755-2020: Reports have been received about the transcutaneous monitoring system display flickering or monitor becoming non responsive and beeping. This may result in delayed patient monitoring as well as potent
- Nov 18, 2015 · Class II · Z-1595-2016: Radiometer America, Inc. is recalling TCM CombiM on rare occasions they may have an error that can cause the alarm to sound higher than the pre-set maximum volume.
- Jul 16, 2015 · Class II · Z-2417-2015: When the fixation ring is taken off the paper liner there is a potential for fractions of the paper liner's surface coating to stick to the surface of the ring.

## Indications for use
The TCM CombiM Monitoring Systems is intended for continuous monitoring of transcutaneous Carbon Dioxide (tcpCO2), oxygen (tcpO2) partial pressure in neonates, pediatrics and adults not under gas anesthesia. The TCM TOSCA Monitoring Systems is intended for continuous monitoring of transcutaneous Carbon Dioxide (tcpCO2), oxygen saturation of arterial haemoglobin (SpO2) and pulse rate in pediatrics and adults.

Source page: https://510kreport.com/device/K093154
Methodology: https://510kreport.com/methodology