# K063443: Draeger Alcotest 6510

- Pathway: 510(k) (Traditional)
- Applicant: Drager Safety
- Decided: Mar 11, 2008 after 483 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: 2 generations back to K041334 (2004). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052804: Breathkey Model G10/Breathkey Model G30X, Omega Point Systems, LLC (2005) Summary page 1.

## Most influential descendants
- K090766: Lifeguard Backtrack B90 Breath Alcohol Tester (2009), 0 descendants of its own

## Indications for use
The Dräger Alcotest 6510 is a device intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.

Source page: https://510kreport.com/device/K063443
Methodology: https://510kreport.com/methodology