# K052804: Breathkey Model G10/Breathkey Model G30X

- Pathway: 510(k) (Traditional)
- Applicant: Omega Point Systems, LLC
- Decided: Dec 9, 2005 after 66 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.
2 later devices descend 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)
- K041334: Alcomate, Model CA2000, Khn Solutions, LLC (2004) Summary page 1.
- (no number) Intoxilyzer S-D5: named in the summary without a submission number

## Most influential descendants
- K063443: Draeger Alcotest 6510 (2008), 1 descendant of its own
- K090766: Lifeguard Backtrack B90 Breath Alcohol Tester (2009), 0 descendants of its own

## Indications for use
OmegaPoint Systems Personal Breath Alcohol Tester BreathKey Model g10 and BreathKey Model g3OX are indicated for use to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication. BreathKey Model g3OX transmits the BAC results to an interlock receiver installed in a motor vehicle

Source page: https://510kreport.com/device/K052804
Methodology: https://510kreport.com/methodology