# K980756: Corometrics Transcutaneous TCPO2/CO2 Module

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies
- Decided: Nov 5, 1998 after 251 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 K900598 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K900333: E5280 Combined Transcutaneous TCP02/TCPCO2 Elect., Radiometer America, Inc. (1990) Summary page 1.
- K954852: Solar 9000 Anesthesia Information Monitor, Marquette Electronics, Inc. (1996) Summary page 1.

## Indications for use
The Corometrics TCpO₂/CO₂ Module is used for non-invasive continuous monitoring of oxygen and/or carbon dioxide when used with the Marquette Medical System’s Solar Monitor Series and TRAM-RAC 4A. It is indicated for use as a monitor of oxygen and/or carbon dioxide in neonates not under anesthesia.

Source page: https://510kreport.com/device/K980756
Methodology: https://510kreport.com/methodology