510(k) · Cleared

Cleared

Bactrack Select Breathalyzer, Models S30, S50, S70

K083801510(k) TraditionalCleared Mar 19, 200987-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

Khn Solutions, LLC · DJZ Devices, Breath Trapping, Alcohol

Cleared on Mar 19, 2009 as substantially equivalent to K061922 (Sentech Korea Corp., 2006) after an 87-day review. Its family tree reaches back 2 generations to 2004.

Decided: Mar 19, 2009
Review: 87 days
Class: Class I
Product code: DJZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K041334 (2004). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK041334 Alcomate, Model CA2000Khn Solutions, LLC · 2004
1 generation backK061922 Breath Alcohol Test System, Model AL-5000Sentech Korea Corp. · 2006
This deviceK083801 Bactrack Select Breathalyzer, Models S30, S50, S70Khn Solutions, LLC · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K041334	Alcomate, Model CA2000	Khn Solutions, LLC	2004	—
−1	K061922	Breath Alcohol Test System, Model AL-5000	Sentech Korea Corp.	2006	—
0 (this device)	K083801	Bactrack Select Breathalyzer, Models S30, S50, S70	Khn Solutions, LLC	2009	—

FIG. 1 — Lineage of K083801, 2004–2009Source: 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
*	K061922	Breath Alcohol Test System, Model AL-5000 Summary page 1 …) Classification Name/Product Code: Devices, breath trapping, alcohol, DJZ Common/Usual Name: Breath Alcohol Tester 2. Equivalent legally marketed device: AL-5000 K061922, SENTECH KOREA CORP. 3. Indications for Use (intended use) This device is intended to measure alcohol in human breath. Measur…	Sentech Korea Corp.	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 2 companies; a new generation was cleared every 2.4 years on median.
None of the 2 ancestors has a recall.

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. 2009, 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?

This device is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K083801 · printed Nov 4, 2026

Cite this page

510(k) Report. “K083801: Bactrack Select Breathalyzer, Models S30, S50, S70.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083801

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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