510(k) · Cleared
ClearedBreath Alcohol Check .02 and Breathscan .02 Detection Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Akers Biosciences, Inc. · DJZ Devices, Breath Trapping, Alcohol
Cleared on Dec 18, 2006 as substantially equivalent to K052448 (Connectables, LLC, 2006) after an 80-day review. Its family tree reaches back 3 generations to 2004. 1 later device descends from it.
- Decided
- Dec 18, 2006
- Review
- 80 days
- Class
- Class I
- Product code
- DJZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K041334 (2004). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK041334 Alcomate, Model CA2000Khn Solutions, LLC · 2004
- 2 generations backK043188 Alcohawk PrecisionQ3 Innovations, LLC · 2005
- 1 generation backK052448 Pocket Breathalyzer. ConnectablesConnectables, LLC · 2006
- This deviceK062971 Breath Alcohol Check .02 and Breathscan .02 Detection SystemsAkers Biosciences, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK102338 Breathscn ProAkers Biosciences, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K102338Breathscn ProAkers Biosciences, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K041334 | Alcomate, Model CA2000 | Khn Solutions, LLC | 2004 | — |
| −2 | K043188 | Alcohawk Precision | Q3 Innovations, LLC | 2005 | — |
| −1 | K052448 | Pocket Breathalyzer. Connectables | Connectables, LLC | 2006 | — |
| 0 (this device) | K062971 | Breath Alcohol Check .02 and Breathscan .02 Detection Systems | Akers Biosciences, Inc. | 2006 | — |
| +1 | K102338 | Breathscn Pro | Akers Biosciences, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K052448 | Pocket Breathalyzer. ConnectablesSummary page 1…System and BreathScan® .02 Breath Alcohol Detection System are equivalent to: CONNECTABLES® Alcohol Tester manufactured by Connectables, LLC in Waukegan, IL (K052448). 5.5 Indications for Use The Breath Alcohol o® .02 Detection System and BreathScan® .02 Breath Alcohol Detection S… | 2006 |
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 |
|---|---|---|---|
| K102338 | Breathscn Pro | 2011 | 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 2 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K102338 (Akers Biosciences, Inc., 2011) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K052448.
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?
The Breath Alcohol UI® .02 Detection System and BreathScan® .02 Breath Alcohol Detection System are in vitro medical devices that qualitatively detect the presence of alcohol in the human breath. The test system detects equal to or greater than 0.02 percent breath alcohol. The system is used only as a screening device and is only an indication of the possible presence of alcohol in the blood of the test subject.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062971 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062971: Breath Alcohol Check .02 and Breathscan .02 Detection Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062971
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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