510(k) · Cleared
ClearedDraeger Alcotest 6510
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Drager Safety · DJZ Devices, Breath Trapping, Alcohol
Cleared on Mar 11, 2008 as substantially equivalent to K052804 (Omega Point Systems, LLC, 2005) after a 483-day review. Its family tree reaches back 2 generations to 2004. 1 later device descends from it.
- Decided
- Mar 11, 2008
- Review
- 483 days
- Class
- Class I
- Product code
- DJZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K041334 (2004). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK041334 Alcomate, Model CA2000Khn Solutions, LLC · 2004
- 1 generation backK052804 Breathkey Model G10/Breathkey Model G30XOmega Point Systems, LLC · 2005
- This deviceK063443 Draeger Alcotest 6510Drager Safety · 2008
- Descendant · cites it directly · 0 of its ownK090766 Lifeguard Backtrack B90 Breath Alcohol TesterLifeloc Technologies, Inc. · 2009
Most influential descendants
Showing 1 of 1 · See all- K090766Lifeguard Backtrack B90 Breath Alcohol TesterLifeloc Technologies, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K041334 | Alcomate, Model CA2000 | Khn Solutions, LLC | 2004 | — |
| −1 | K052804 | Breathkey Model G10/Breathkey Model G30X | Omega Point Systems, LLC | 2005 | — |
| 0 (this device) | K063443 | Draeger Alcotest 6510 | Drager Safety | 2008 | — |
| +1 | K090766 | Lifeguard Backtrack B90 Breath Alcohol Tester | Lifeloc Technologies, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K052804 | Breathkey Model G10/Breathkey Model G30XSummary page 1…65 10 is equivalent to the following: OmegaPoint Systems Personal Breath Alcohol Tester BreathKeyTM Model 61 0 and BreathKeyTM Model G30X (K052804) 4. Indications for Use The Drager Alcotest 65 10 is an apparatus for indicating the presence of alcohol in th… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090766 | Lifeguard Backtrack B90 Breath Alcohol Tester | 2009 | 0 |
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?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K090766 (Lifeloc Technologies, Inc., 2009) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DJZ devicesDJZ Devices, Breath Trapping, Alcohol: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063443 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063443: Draeger Alcotest 6510.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063443
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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