510(k) · Cleared

Cleared

Alcohawk Precision

K043188510(k) TraditionalCleared Feb 9, 200584-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

Q3 Innovations, LLC · DJZ Devices, Breath Trapping, Alcohol

Cleared on Feb 9, 2005 as substantially equivalent to K041334 (Khn Solutions, LLC, 2004) after an 84-day review. Its family tree reaches back 1 generation to 2004. 15 later devices descend from it.

Decided: Feb 9, 2005
Review: 84 days
Class: Class I
Product code: DJZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K041334 (2004). 15 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK041334 Alcomate, Model CA2000Khn Solutions, LLC · 2004
This deviceK043188 Alcohawk PrecisionQ3 Innovations, LLC · 2005
Descendant · cites it directly · 8 of its ownK052448 Pocket Breathalyzer. ConnectablesConnectables, LLC · 2006
Descendant · cites it directly · 5 of its ownK080848 Alcohawk Model PT500 Digital Alcohol DetectorQ3 Innovations, LLC · 2008
Descendant · 2 generations on · 3 of its ownK060761 Breathscan, Breath and Breath Check Alcohol DetectorsAkers Biosciences, Inc. · 2006
Descendant · 2 generations on · 1 of its ownK123470 Pas Alcovisor Mars, Pas Alcovisor SatellitePas Systems International, Inc. · 2013
Descendant · 2 generations on · 1 of its ownK062971 Breath Alcohol Check .02 and Breathscan .02 Detection SystemsAkers Biosciences, Inc. · 2006

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2006high 4 (2009) · low 0 (2012)2026

Most influential descendants

Showing 5 of 15 · See all

K052448Pocket Breathalyzer. ConnectablesConnectables, LLC · 2006 · cites it directly8descendants
K080848Alcohawk Model PT500 Digital Alcohol DetectorQ3 Innovations, LLC · 2008 · cites it directly5descendants
K060761Breathscan, Breath and Breath Check Alcohol DetectorsAkers Biosciences, Inc. · 2006 · 2 generations on3descendants
K123470Pas Alcovisor Mars, Pas Alcovisor SatellitePas Systems International, Inc. · 2013 · 2 generations on1descendant
K062971Breath Alcohol Check .02 and Breathscan .02 Detection SystemsAkers Biosciences, Inc. · 2006 · 2 generations on1descendant

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)	K043188	Alcohawk Precision	Q3 Innovations, LLC	2005	—
+1	K052448	Pocket Breathalyzer. Connectables	Connectables, LLC	2006	—
+1	K080848	Alcohawk Model PT500 Digital Alcohol Detector	Q3 Innovations, LLC	2008	—
+2	K060761	Breathscan, Breath and Breath Check Alcohol Detectors	Akers Biosciences, Inc.	2006	—
+2	K123470	Pas Alcovisor Mars, Pas Alcovisor Satellite	Pas Systems International, Inc.	2013	—
+2	K062971	Breath Alcohol Check .02 and Breathscan .02 Detection Systems	Akers Biosciences, Inc.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	3	0
2007	1	0
2008	2	0
2009	4	0
2010	1	0
2011	2	0
2013	1	0
2016	1	0

FIG. 1 — Lineage of K043188, 2004–2016Source: 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
*	K041334	Alcomate, Model CA2000 Summary page 1 …mon/LUsual Name: Breath-alcohol test system 2. Equivalent legally marketed devices AlcoMate CA2000TM Digital Alcohol Detector manufactured by Han International, K04 1334 3. Indications for Use (intended use) :The device is intended to measure alcohol in the human breath. Measurements obtai…	Khn Solutions, LLC	2004	—

Also cleared against K041334: 6 other devices →

What descends from it? (15)

See all 15

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K052448	Pocket Breathalyzer. Connectables	Connectables, LLC	2006	8
K080848	Alcohawk Model PT500 Digital Alcohol Detector	Q3 Innovations, LLC	2008	5

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.
Of its descendants, K052448 (Connectables, LLC, 2006) has gone furthest, with 8 descendants of its own.
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?

Intended to measure alcohol in the 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/K043188 · printed Nov 6, 2026

Cite this page

510(k) Report. “K043188: Alcohawk Precision.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043188

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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