# K060761: Breathscan, Breath and Breath Check Alcohol Detectors

- Pathway: 510(k) (Traditional)
- Applicant: Akers Biosciences, Inc.
- Decided: Apr 28, 2006 after 38 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.
3 later devices descend from it; 3 cite it directly.
0 of 7 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
- K102225: Alco-Breath Tube, Checkpoint Breath Alcohol Test (2011), 0 descendants of its own
- K093143: Mission Breath Alcohol Detector (2010), 0 descendants of its own
- K082080: Alco Tube Plus (2009), 0 descendants of its own

## Indications for use
The BreathScan® Alcohol Detector is an in vitro medical device to qualitatively detect the presence of alcohol in the human breath. It is a disposable screening device for one-time use. The detector is available at several detection cut-offs including 0.02, 0.04, 0.05, and 0.08 percent breath alcohol. The device 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/K060761
Methodology: https://510kreport.com/methodology