# K171408: Carbon Monoxide Breath Sensor System (COBSS)

- Pathway: 510(k) (Traditional)
- Applicant: Carrot Sense, Inc.
- Decided: Sep 29, 2017 after 140 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: 1 generation back to K082315 (2010). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082315: EC50 Micro+ Smokerlyzer, Bedfont Scientific, Ltd. (2010) Summary page 4.

## Most influential descendants
- K211918: iCOquit® Smokerlyzer® (2021), 0 descendants of its own
- K201206: Pivot Breath Sensor (2021), 0 descendants of its own

## Indications for use
The Carbon Monoxide Breath Sensor System (COBSS) is a breath carbon monoxide monitor intended for single-user use by cigarette smokers in smoking cessation programs to inform the user about how breath carbon monoxide levels are affected by smoking behavior. The device is not intended to be used with other inhaled products.

Source page: https://510kreport.com/device/K171408
Methodology: https://510kreport.com/methodology