# K121768: Cosense

- Pathway: 510(k) (Traditional)
- Applicant: Capnia, Inc.
- Decided: Oct 31, 2012 after 138 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: 2 generations back to K000962 (2000). 2 ancestors in all.
3 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)
- K080278: Tabataba Cotester, Fim Medical (2008) Summary page 1.

## Most influential descendants
- K130036: Cosense CO Monitor (2014), 2 descendants of its own
- 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 CO Monitor is indicated for the monitoring of Carbon Monoxide from endogenous and exogenous sources in exhaled breath. It is for use in smoking cessation programs and can be used for the screening of CO poisoning and smoke inhalation. It is for use by health professionals.

Source page: https://510kreport.com/device/K121768
Methodology: https://510kreport.com/methodology