510(k) · Cleared
ClearedAlcohawk Model PT500 Digital Alcohol Detector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Q3 Innovations, LLC · DJZ Devices, Breath Trapping, Alcohol
Cleared on Jul 25, 2008 as substantially equivalent to K043188 (Q3 Innovations, LLC, 2005) after a 121-day review. Its family tree reaches back 2 generations to 2004. 5 later devices descend from it.
- Decided
- Jul 25, 2008
- Review
- 121 days
- Class
- Class I
- Product code
- DJZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K041334 (2004). 5 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK041334 Alcomate, Model CA2000Khn Solutions, LLC · 2004
- 1 generation backK043188 Alcohawk PrecisionQ3 Innovations, LLC · 2005
- This deviceK080848 Alcohawk Model PT500 Digital Alcohol DetectorQ3 Innovations, LLC · 2008
- Descendant · cites it directly · 1 of its ownK123470 Pas Alcovisor Mars, Pas Alcovisor SatellitePas Systems International, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK160613 Soberlink Cellular Device and Sober Sky Web PortalSoberlink Healthcare, LLC · 2016
- Descendant · cites it directly · 0 of its ownK091714 Alcodigital Breathalyzer, Model AT576, AT577, AT578, AT579Skyfine Inc. Limited · 2009
- Descendant · cites it directly · 0 of its ownK090766 Lifeguard Backtrack B90 Breath Alcohol TesterLifeloc Technologies, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK090067 Bactrack Select Breathalyzer, Model S80Khn Solutions, LLC · 2009
Most influential descendants
Showing 5 of 5 · See all- K123470Pas Alcovisor Mars, Pas Alcovisor SatellitePas Systems International, Inc. · 2013 · cites it directly1descendant
- K160613Soberlink Cellular Device and Sober Sky Web PortalSoberlink Healthcare, LLC · 2016 · 2 generations on0descendants
- K091714Alcodigital Breathalyzer, Model AT576, AT577, AT578, AT579Skyfine Inc. Limited · 2009 · cites it directly0descendants
- K090766Lifeguard Backtrack B90 Breath Alcohol TesterLifeloc Technologies, Inc. · 2009 · cites it directly0descendants
- K090067Bactrack Select Breathalyzer, Model S80Khn Solutions, LLC · 2009 · cites it directly0descendants
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 | K043188 | Alcohawk Precision | Q3 Innovations, LLC | 2005 | — |
| 0 (this device) | K080848 | Alcohawk Model PT500 Digital Alcohol Detector | Q3 Innovations, LLC | 2008 | — |
| +1 | K123470 | Pas Alcovisor Mars, Pas Alcovisor Satellite | Pas Systems International, Inc. | 2013 | — |
| +2 | K160613 | Soberlink Cellular Device and Sober Sky Web Portal | Soberlink Healthcare, LLC | 2016 | — |
| +1 | K091714 | Alcodigital Breathalyzer, Model AT576, AT577, AT578, AT579 | Skyfine Inc. Limited | 2009 | — |
| +1 | K090766 | Lifeguard Backtrack B90 Breath Alcohol Tester | Lifeloc Technologies, Inc. | 2009 | — |
| +1 | K090067 | Bactrack Select Breathalyzer, Model S80 | Khn Solutions, LLC | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 3 | 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 |
|---|---|---|---|
| * | K043188 | Alcohawk PrecisionSummary page 1…l Alcohol Detector Classification Name: Device, breath trapping, alcohol, DJZ Common/Usual Name: Breath-alcohol test system 2. Equivalent legally marketed devices K043188 AlcoHAWK® Precision Alcohol Detector, Q3 Innovations LLC 3. Indications for Use (intended use): This device is intended to me… | 2005 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K123470 (Pas Systems International, Inc., 2013) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K043188.
How does its category compare?
All DJZ devicesDJZ Devices, Breath Trapping, Alcohol: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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?
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/K080848 · printed Nov 5, 2026
Cite this page
510(k) Report. “K080848: Alcohawk Model PT500 Digital Alcohol Detector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K080848
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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