# K090766: Lifeguard Backtrack B90 Breath Alcohol Tester

- Pathway: 510(k) (Traditional)
- Applicant: Lifeloc Technologies, Inc.
- Decided: Jul 23, 2009 after 122 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). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063443: Draeger Alcotest 6510, Drager Safety (2008) Summary page 1.
- K080848: Alcohawk Model PT500 Digital Alcohol Detector, Q3 Innovations, LLC (2008) Summary page 1.

## Indications for use
The LifeGuard and BacTrack B90 devices are intended to measure alcohol in human breath. Measurements obtained from these devices are used in the diagnosis of alcohol intoxication. The LifeGuard and BacTrack B90 devices are intended to be used by the general adult population and by qualified personnel, such as physicians, nurses, and technicians. The LifeGuard and BacTrack B90 devices are intended to be used by adults (age 21 and over) in measuring alcohol intoxication in themselves or others. The LifeGuard and BacTrack B90 devices are intended to be used in both home (over-the-counter) and clinical settings.

Source page: https://510kreport.com/device/K090766
Methodology: https://510kreport.com/methodology