510(k) · Cleared
ClearedAlco Tube Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcotest Quebec · DJZ Devices, Breath Trapping, Alcohol
Cleared on Apr 1, 2009 as substantially equivalent to K060761 (Akers Biosciences, Inc., 2006) after a 252-day review. Its family tree reaches back 4 generations to 2004.
- Decided
- Apr 1, 2009
- Review
- 252 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 backK060761 Breathscan, Breath and Breath Check Alcohol DetectorsAkers Biosciences, Inc. · 2006
- This deviceK082080 Alco Tube PlusAlcotest Quebec · 2009
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 | K060761 | Breathscan, Breath and Breath Check Alcohol Detectors | Akers Biosciences, Inc. | 2006 | — |
| 0 (this device) | K082080 | Alco Tube Plus | Alcotest Quebec | 2009 | — |
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 |
|---|---|---|---|
| * | K060761 | Breathscan, Breath and Breath Check Alcohol DetectorsSummary page 1…Device: Company Product 510(k) # Akers Biosciences, Inc. BreathScan® Alcohol Detector K060761 DEVICE DESCRIPTION 807.92(a)(4) The Alco Tube Plus Alcohol Detector (Tester) is a vis… | 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 5 years and passes through 5 companies; a new generation was cleared every 1.0 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K060761.
How does its category compare?
All DJZ devicesDJZ Devices, Breath Trapping, Alcohol: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Alco Tube Plus Alcohol Detector is an in vitro medical device to qualitatively
detect the presence of alcohol in the human breath. It is a disposable screening
device for one-time use. The detector is available in two cut-offs including 0.05
and 0.08 percent breath alcohol. The device 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/K082080 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082080: Alco Tube Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082080
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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