# K201206: Pivot Breath Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Carrot, Inc.
- Decided: Jun 30, 2021 after 422 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 K082315 (2010). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171408: Carbon Monoxide Breath Sensor System (COBSS), Carrot Sense, Inc. (2017) Summary page 4.

## Indications for use
The Pivot Breath Sensor is a breath carbon monoxide monitor intended for single-user use by cigarette smokers as an educational and motivational tool 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 combustible, inhaled products.

Source page: https://510kreport.com/device/K201206
Methodology: https://510kreport.com/methodology