510(k) · Cleared
ClearedAlcomate, Model CA2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Khn Solutions, LLC · DJZ Devices, Breath Trapping, Alcohol
Cleared on Aug 11, 2004 after an 84-day review. The FDA summary names its predicate without a number. 23 later devices descend from it.
- Decided
- Aug 11, 2004
- Review
- 84 days
- Class
- Class I
- Product code
- DJZ
- Recalls
- None
- Predicates
- 0
23 later devices descend from it, 7 citing it directly.
- This deviceK041334 Alcomate, Model CA2000Khn Solutions, LLC · 2004
- Descendant · cites it directly · 15 of its ownK043188 Alcohawk PrecisionQ3 Innovations, LLC · 2005
- Descendant · 2 generations on · 8 of its ownK052448 Pocket Breathalyzer. ConnectablesConnectables, LLC · 2006
- Descendant · 2 generations on · 5 of its ownK080848 Alcohawk Model PT500 Digital Alcohol DetectorQ3 Innovations, LLC · 2008
- Descendant · 3 generations on · 3 of its ownK060761 Breathscan, Breath and Breath Check Alcohol DetectorsAkers Biosciences, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK052804 Breathkey Model G10/Breathkey Model G30XOmega Point Systems, LLC · 2005
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K043188Alcohawk PrecisionQ3 Innovations, LLC · 2005 · cites it directly15descendants
- K052448Pocket Breathalyzer. ConnectablesConnectables, LLC · 2006 · 2 generations on8descendants
- K080848Alcohawk Model PT500 Digital Alcohol DetectorQ3 Innovations, LLC · 2008 · 2 generations on5descendants
- K060761Breathscan, Breath and Breath Check Alcohol DetectorsAkers Biosciences, Inc. · 2006 · 3 generations on3descendants
- K052804Breathkey Model G10/Breathkey Model G30XOmega Point Systems, LLC · 2005 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041334 | Alcomate, Model CA2000 | Khn Solutions, LLC | 2004 | — |
| +1 | K043188 | Alcohawk Precision | Q3 Innovations, LLC | 2005 | — |
| +2 | K052448 | Pocket Breathalyzer. Connectables | Connectables, LLC | 2006 | — |
| +2 | K080848 | Alcohawk Model PT500 Digital Alcohol Detector | Q3 Innovations, LLC | 2008 | — |
| +3 | K060761 | Breathscan, Breath and Breath Check Alcohol Detectors | Akers Biosciences, Inc. | 2006 | — |
| +1 | K052804 | Breathkey Model G10/Breathkey Model G30X | Omega Point Systems, LLC | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 5 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 5 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
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 |
|---|---|---|---|
| * | — | Alco-Sensor Named without a submission number |
What descends from it? (23)
See all 237 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043188 | Alcohawk Precision | 2005 | 15 |
| K052804 | Breathkey Model G10/Breathkey Model G30X | 2005 | 2 |
| K061922 | Breath Alcohol Test System, Model AL-5000 | 2006 | 1 |
| K081855 | Impair Aware Alcohol Level Indication System (Alis) | 2008 | 0 |
| K071067 | Bactrack LCD Alcohol Detector | 2007 | 0 |
| K062545 | Rmi LCD Alcohol Detector | 2007 | 0 |
| K060343 | Breath Alcohol Test System, Model AL-6000 | 2006 | 0 |
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?
- Of its descendants, K043188 (Q3 Innovations, LLC, 2005) has gone furthest, with 15 descendants of its own.
How does its category compare?
All DJZ devicesDJZ Devices, Breath Trapping, Alcohol: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
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/K041334 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041334: Alcomate, Model CA2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041334
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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