510(k) · Cleared
ClearedBreathkey Model G10/Breathkey Model G30X
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omega Point Systems, LLC · DJZ Devices, Breath Trapping, Alcohol
Cleared on Dec 9, 2005 as substantially equivalent to K041334 (Khn Solutions, LLC, 2004) after a 66-day review. Its family tree reaches back 1 generation to 2004. 2 later devices descend from it.
- Decided
- Dec 9, 2005
- Review
- 66 days
- Class
- Class I
- Product code
- DJZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K041334 (2004). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK041334 Alcomate, Model CA2000Khn Solutions, LLC · 2004
- This deviceK052804 Breathkey Model G10/Breathkey Model G30XOmega Point Systems, LLC · 2005
- Descendant · cites it directly · 1 of its ownK063443 Draeger Alcotest 6510Drager Safety · 2008
- Descendant · 2 generations on · 0 of its ownK090766 Lifeguard Backtrack B90 Breath Alcohol TesterLifeloc Technologies, Inc. · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K041334 | Alcomate, Model CA2000 | Khn Solutions, LLC | 2004 | — |
| 0 (this device) | K052804 | Breathkey Model G10/Breathkey Model G30X | Omega Point Systems, LLC | 2005 | — |
| +1 | K063443 | Draeger Alcotest 6510 | Drager Safety | 2008 | — |
| +2 | K090766 | Lifeguard Backtrack B90 Breath Alcohol Tester | Lifeloc Technologies, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DJZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K041334 | Alcomate, Model CA2000Summary page 1…862.3050 Predicate Device(s) AlcoMate CA2000 Digital Alcohol Detector manufactured by KH-N Solutions LLC 510(k) Premarket Notification number: K04 1334 FDA Product Code: DJZ Intoxilyzer S-D5, manufactured by CMI, Inc DOT approved device 69 FR 42237… | 2004 |
| * | — | Intoxilyzer S-D5 Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063443 | Draeger Alcotest 6510 | 2008 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All DJZ devicesDJZ Devices, Breath Trapping, Alcohol: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DJZ
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · DJZ
240in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJZ
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DJZ
3in 2025
MAUDE reports naming product code DJZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 1 | 2 |
| 2008 | 5 | 149 | 0 | 0 |
| 2009 | 5 | 122 | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 3 | 240 | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052804 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052804: Breathkey Model G10/Breathkey Model G30X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052804
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026