510(k) · Cleared

Cleared

Breath Alcohol Test System, Model AL-6000

K060343510(k) TraditionalCleared May 11, 200690-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

Sentech Korea Corp. · DJZ Devices, Breath Trapping, Alcohol

Cleared on May 11, 2006 as substantially equivalent to K041334 (Khn Solutions, LLC, 2004) after a 90-day review. Its family tree reaches back 1 generation to 2004.

Decided: May 11, 2006
Review: 90 days
Class: Class I
Product code: DJZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K041334 (2004). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK041334 Alcomate, Model CA2000Khn Solutions, LLC · 2004
This deviceK060343 Breath Alcohol Test System, Model AL-6000Sentech Korea Corp. · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K041334	Alcomate, Model CA2000	Khn Solutions, LLC	2004	—
0 (this device)	K060343	Breath Alcohol Test System, Model AL-6000	Sentech Korea Corp.	2006	—

FIG. 1 — Lineage of K060343, 2004–2006Source: 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

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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
*	K041334	Alcomate, Model CA2000 Summary page 1 …, Breath Trapping, Alcohol, DJZ Common Name: Breath Alcohol Test System 2. Equivalent Legally Marketed Device AlcoMate (Model CA2000) - KHN Solutions, LLC / K041334 3. Indications for Use (Intended Use) The AL-6000 is intended to measure alcohol in the human breath. Measurements o…	Khn Solutions, LLC	2004	—

Also cleared against K041334: 6 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?

Its one ancestor has no recall.
6 other devices also cite its predicate K041334.

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.

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 AL-6000 Breath Alcohol Tester is a screening device for the rapid detection of alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcoholic intoxication.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060343 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060343: Breath Alcohol Test System, Model AL-6000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060343

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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