# K110614: Pad (Personal Alcohol Detector) Breath Alcohol Test System

- Pathway: 510(k) (Traditional)
- Applicant: Seju Engineering Co., Ltd.
- Decided: Nov 21, 2011 after 263 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: 1 generation back to K053332 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053332: Breath Alcohol Test System, Model AL 2500, Sentech Korea Corp. (2006) Summary page 1.

## Indications for use
The PAD Breath Alcohol Test System is a screening device for the rapid detection of alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcoholic intoxication.

Source page: https://510kreport.com/device/K110614
Methodology: https://510kreport.com/methodology