# K081855: Impair Aware Alcohol Level Indication System (Alis)

- Pathway: 510(k) (Traditional)
- Applicant: Canada, Inc.
- Decided: Dec 19, 2008 after 172 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 K041334 (2004). 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)
- K041334: Alcomate, Model CA2000, Khn Solutions, LLC (2004) Summary page 3.

## Indications for use
The IA ALIS device is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnostic of alcohol intoxication.

Source page: https://510kreport.com/device/K081855
Methodology: https://510kreport.com/methodology