# K130036: Cosense CO Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Capnia, Inc.
- Decided: Jan 14, 2014 after 372 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: 3 generations back to K000962 (2000). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121768: Cosense, Capnia, Inc. (2012) Summary page 1.

## Most influential descendants
- K151107: CoSense ETCO Monitor (2015), 1 descendant of its own
- K253119: CoSense ETCO Monitor (2026), 0 descendants of its own

## 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 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/K130036
Methodology: https://510kreport.com/methodology