# K041334: Alcomate, Model CA2000

- Pathway: 510(k) (Traditional)
- Applicant: Khn Solutions, LLC
- Decided: Aug 11, 2004 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
No predicates in its family tree.
23 later devices descend from it; 7 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Alco-Sensor: named in the summary without a submission number

## Most influential descendants
- K043188: Alcohawk Precision (2005), 15 descendants of its own
- 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
- K052804: Breathkey Model G10/Breathkey Model G30X (2005), 2 descendants 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/K041334
Methodology: https://510kreport.com/methodology