# K102338: Breathscn Pro

- Pathway: 510(k) (Traditional)
- Applicant: Akers Biosciences, Inc.
- Decided: Jan 12, 2011 after 147 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: 4 generations back to K041334 (2004). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062971: Breath Alcohol Check .02  and Breathscan .02 Detection Systems, Akers Biosciences, Inc. (2006) Summary page 1.

## Indications for use
The BreathScanoPRO is an in vitro medical device that quantitatively the presence of alcohol in the human breath. The device is used only as a screening device and is an indication of the possible presence of alcohol in the blood of the test subject.

Source page: https://510kreport.com/device/K102338
Methodology: https://510kreport.com/methodology