510(k) · Cleared

Cleared

Alco-Breath Tube, Checkpoint Breath Alcohol Test

K102225510(k) TraditionalCleared Apr 6, 2011240-day reviewClass I21 CFR 862.3050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Alcopro, Inc. · DJZ Devices, Breath Trapping, Alcohol

Cleared on Apr 6, 2011 as substantially equivalent to K060761 (Akers Biosciences, Inc., 2006) after a 240-day review. Its family tree reaches back 4 generations to 2004.

Decided: Apr 6, 2011
Review: 240 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.

By dateBy generation

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 deviceK102225 Alco-Breath Tube, Checkpoint Breath Alcohol TestAlcopro, 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	K060761	Breathscan, Breath and Breath Check Alcohol Detectors	Akers Biosciences, Inc.	2006	—
0 (this device)	K102225	Alco-Breath Tube, Checkpoint Breath Alcohol Test	Alcopro, Inc.	2011	—

FIG. 1 — Lineage of K102225, 2004–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K060761	Breathscan, Breath and Breath Check Alcohol Detectors Summary page 1 …862.3050 - Tox icology Classification Product Code: 017 Classification: Class I Substantially Equivalent Devices: K060761 - BreathScan Alcohol Detector Device Description: The Alco-Breath Tube is a disposable, one-time use in vitro diagnostic (IVD)…	Akers Biosciences, Inc.	2006	—

Also cleared against K060761: 2 other devices →

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 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 devices

DJZ 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

2007high 5 (2008) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DJZ

240in 2011

2007high 240 (2011) · low 122 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DJZ

1in 2007

2007high 1 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DJZ

3in 2025

2007high 3 (2025) · low 0 (2008)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 CheckPoint breath alcohol test is a device to test for alcohol in human breath, It is a disposable device designed for one-time use and is a screening test that gives preliminary results. The test is available at cut-offs of 0.02, 0.04, 0.05, and 0.08% BAG.

The Alco-Breath Tube is a device to test for alcohol in human breath. It is a disposable device designed for one-time use and is a screening test that gives preliminary results. This device provides a semi-quantitative estimate of alcohol levels in breath. The ABT-08 device gives readings between 0 and 0.08% BAG and the ABT-1 5 device gives readings between 0 and 0.15% BAG.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K102225 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102225: Alco-Breath Tube, Checkpoint Breath Alcohol Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102225

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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