510(k) · Cleared
ClearedKey Ring Alcohol Breathalyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Ashley Collection, Inc. · DJZ Devices, Breath Trapping, Alcohol
Cleared on Dec 19, 2008 as substantially equivalent to K052448 (Connectables, LLC, 2006) after a 149-day review. Its family tree reaches back 3 generations to 2004.
- Decided
- Dec 19, 2008
- Review
- 149 days
- Class
- Class I
- Product code
- DJZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K041334 (2004). No later device cites it as a predicate yet.
- Root · 3 generations backK041334 Alcomate, Model CA2000Khn Solutions, LLC · 2004
- 2 generations backK043188 Alcohawk PrecisionQ3 Innovations, LLC · 2005
- 1 generation backK052448 Pocket Breathalyzer. ConnectablesConnectables, LLC · 2006
- This deviceK082086 Key Ring Alcohol BreathalyzerThe Ashley Collection, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K052448 | Pocket Breathalyzer. ConnectablesSummary page 1…hol Breath Checker Classification Name: Device, breath trapping, alcohol, DJZ Common/Usual Name: Breath-alcohol test system 2. Equivalent legally marketed devices K052448, Connectables Pocket Breathalyzer 3. Indications for Use (intended use): This device is intended to measure alcohol in human bre… | 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 4 years and passes through 4 companies; a new generation was cleared every 1.0 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K052448.
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 devise is intended to measure alcohol in the human breathe.
Measurements obtained by this device are use as an aid in the detection of
alcohol intoxication.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082086 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082086: Key Ring Alcohol Breathalyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082086
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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