# K171828: ETCO2 Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Orantech, Inc.
- Decided: May 31, 2018 after 345 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K920379 (1992). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042601: Capnostat 5, Respironics Novametrix, Inc. (2004) Summary page 4.

## Indications for use
The intended use of the ETCO2 sensor is to provide carbon dioxide monitoring to a host monitoring system during anesthesia / recovery, in the intensive care unit (ICU), and in Emergency Medicine/Transport or Respiratory care.

Source page: https://510kreport.com/device/K171828
Methodology: https://510kreport.com/methodology