# K980287: Siemens SC9000/SC9015 TCP02/C02 Module

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Aug 12, 1998 after 198 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
Longest line of descent: 1 generation back to K891481 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K891481: Siemens Sirecust Transcutaneous Carbon Dioxide, Siemens Medical Electronics (1989) Summary page 1.
- K900333: E5280 Combined Transcutaneous TCP02/TCPCO2 Elect., Radiometer America, Inc. (1990) Summary page 1.

## Indications for use
Siemens Transcutaneous tpO2/CO2 Gas Module is indicated for use to continuously monitor the noninvasive trending of transcutaneous oxygen in the neonatal population when the patient is not under gas anesthesia. Siemens Transcutaneous tpO2/CO2 Gas Module is indicated for use to continuously monitor the noninvasive trending of transcutaneous carbon dioxide partial pressure in any patient population. The device is indicated for use in an environment where patient care is provided by healthcare professionals, i.e. Physicians, Nurses, Technicians, when the professional determines that the device is required.

Source page: https://510kreport.com/device/K980287
Methodology: https://510kreport.com/methodology