# K253119: CoSense ETCO Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Capnia, Inc.
- Decided: May 29, 2026 after 247 days
- Product code: CCJ (Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1430
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K000962 (2000). 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)
- K151107: CoSense ETCO Monitor, Capnia, Inc. (2015) Summary page 5.

## Indications for use
The CoSense ETCO Monitor is indicated for the monitoring of carbon monoxide from endogenous sources (including hemolysis) and exogenous sources (including CO poisoning and smoke inhalation) in exhaled breath. The end-tidal carbon monoxide level can be used for the monitoring of carbon monoxide in medical conditions in which the rate of hemolysis may be relevant. It can be used with the pediatric population. It is also for use in smoking cessation programs and can be used for the screening of CO poisoning and smoke inhalation.

Source page: https://510kreport.com/device/K253119
Methodology: https://510kreport.com/methodology