510(k) · Cleared
ClearedBreathscn Pro
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 Jan 12, 2011 as substantially equivalent to K062971 (Akers Biosciences, Inc., 2006) after a 147-day review. Its family tree reaches back 4 generations to 2004.
- Decided
- Jan 12, 2011
- Review
- 147 days
- Class
- Class I
- Product code
- DJZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K041334 (2004). No later device cites it as a predicate yet.
- Root · 4 generations backK041334 Alcomate, Model CA2000Khn Solutions, LLC · 2004
- 3 generations backK043188 Alcohawk PrecisionQ3 Innovations, LLC · 2005
- 2 generations backK052448 Pocket Breathalyzer. ConnectablesConnectables, LLC · 2006
- 1 generation backK062971 Breath Alcohol Check .02 and Breathscan .02 Detection SystemsAkers Biosciences, Inc. · 2006
- This deviceK102338 Breathscn ProAkers Biosciences, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K041334 | Alcomate, Model CA2000 | Khn Solutions, LLC | 2004 | — |
| −3 | K043188 | Alcohawk Precision | Q3 Innovations, LLC | 2005 | — |
| −2 | K052448 | Pocket Breathalyzer. Connectables | Connectables, LLC | 2006 | — |
| −1 | K062971 | Breath Alcohol Check .02 and Breathscan .02 Detection Systems | Akers Biosciences, Inc. | 2006 | — |
| 0 (this device) | K102338 | Breathscn Pro | Akers Biosciences, Inc. | 2011 | — |
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 |
|---|---|---|---|
| * | K062971 | Breath Alcohol Check .02 and Breathscan .02 Detection SystemsSummary page 1…eathScan®PRO is equivalent to: Breath Alcohol 0® .02 Detection System manufactured by ABI (K062971) 5.5 Indications for Use The BreathScan®PRO1 is an in vitro medical device that quantitatively detects the prese… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 7 years and passes through 4 companies; a new generation was cleared every 1.0 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All DJZ devicesDJZ Devices, Breath Trapping, Alcohol: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 BreathScanoPRO is an in vitro medical device that quantitatively the presence of alcohol in the human breath. The device is used only as a screening device and is 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/K102338 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102338: Breathscn Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102338
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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