# K062971: Breath Alcohol Check .02  and Breathscan .02 Detection Systems

- Pathway: 510(k) (Traditional)
- Applicant: Akers Biosciences, Inc.
- Decided: Dec 18, 2006 after 80 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.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052448: Pocket Breathalyzer. Connectables, Connectables, LLC (2006) Summary page 1.

## Most influential descendants
- K102338: Breathscn Pro (2011), 0 descendants of its own

## Indications for use
The Breath Alcohol UI® .02 Detection System and BreathScan® .02 Breath Alcohol Detection System are in vitro medical devices that qualitatively detect the presence of alcohol in the human breath. The test system detects equal to or greater than 0.02 percent breath alcohol. The system is used only as a screening device and is only an indication of the possible presence of alcohol in the blood of the test subject.

Source page: https://510kreport.com/device/K062971
Methodology: https://510kreport.com/methodology