# K043003: TCM40 Monitoring System

- Pathway: 510(k) (Abbreviated)
- Applicant: Radiometer Medical Aps
- Decided: Mar 1, 2005 after 120 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
No predicates in its family tree.
89 later devices descend from it; 2 cite it directly.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) TCM400 Monitoring System: named in the summary without a submission number
- (no number) TCM3 Monitoring System: named in the summary without a submission number
- (no number) OxiMAX N-550 Pulse Oximetry System: named in the summary without a submission number
- (no number) TOSCA PCO2, SpO2 and Pulse Rate Monitoring System: named in the summary without a submission number
- (no number) Perimed Transcutaneous PO2 and PCO2 Monitor (PF5040): named in the summary without a submission number
- (no number) MicroGas 7650 Transcutaneous Monitor: named in the summary without a submission number
- (no number) Siemens Transcutaneous TpO2/CO2 Gas Module: named in the summary without a submission number

## 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

## 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 27, 2012 · Class II · Z-1930-2013: RADIOMETER became aware that the TCM4 series Base Unit does not comply with IEC 60601-1 Sub Clause 15B.
- Sep 27, 2011 · Not classified · Z-0341-2012: Transcutaneous pCO2-electrodes were wrongly coded as: pO2 electrode on the hardware plug for the firm's TCM series monitors. This causes the monitor to interpret the electrode wrongly, causing it to f

## Indications for use
The TCM4 Monitoring System is intended for continuous transcutaneous monitoring of oxygen and carbon dioxide partial pressures. It is indicated for use on neonates, pediatrics, and adults not under gas anesthesia. The TCM40 Monitoring System is intended for continuous transcutaneous monitoring of oxygen and carbon dioxide partial pressures as well as of oxygen saturation of arterial hemoglobin and pulse rate. It is indicated for use on neonates, pediatrics, and adults not under gas anesthesia.

Source page: https://510kreport.com/device/K043003
Methodology: https://510kreport.com/methodology