# K151107: CoSense ETCO Monitor

- Pathway: 510(k) (Special)
- Applicant: Capnia, Inc.
- Decided: Jul 22, 2015 after 86 days
- Product code: CCJ (Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1430
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K000962 (2000). 4 ancestors in all.
1 later device descends 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)
- K130036: Cosense CO Monitor, Capnia, Inc. (2014) Summary page 4.

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

## Recalls of this device
- Apr 21, 2025 · Class II · Z-2198-2025: Sampling set nasal cannula used with End-Tidal Carbon Monoxide (ETCO) monitor may have residual carbon monoxide and volatile organic compounds present due to insufficient aeration of the cannula's car

## 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/K151107
Methodology: https://510kreport.com/methodology