# K043188: Alcohawk Precision

- Pathway: 510(k) (Traditional)
- Applicant: Q3 Innovations, LLC
- Decided: Feb 9, 2005 after 84 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.
15 later devices descend from it; 2 cite it directly.
0 of 17 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 1.

## Most influential descendants
- K052448: Pocket Breathalyzer. Connectables (2006), 8 descendants of its own
- K080848: Alcohawk Model PT500 Digital Alcohol Detector (2008), 5 descendants of its own
- K060761: Breathscan, Breath and Breath Check Alcohol Detectors (2006), 3 descendants of its own
- K123470: Pas Alcovisor Mars, Pas Alcovisor Satellite (2013), 1 descendant of its own
- K062971: Breath Alcohol Check .02  and Breathscan .02 Detection Systems (2006), 1 descendant of its own

## Indications for use
Intended to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.

Source page: https://510kreport.com/device/K043188
Methodology: https://510kreport.com/methodology