# K090067: Bactrack Select Breathalyzer, Model S80

- Pathway: 510(k) (Traditional)
- Applicant: Khn Solutions, LLC
- Decided: Mar 24, 2009 after 74 days
- Product code: DJZ (Devices, Breath Trapping, Alcohol)
- Device class: 1
- Regulation: 21 CFR 862.3050
- 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 K041334 (2004). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080848: Alcohawk Model PT500 Digital Alcohol Detector, Q3 Innovations, LLC (2008) Summary page 1.

## Indications for use
This device is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.

Source page: https://510kreport.com/device/K090067
Methodology: https://510kreport.com/methodology