510(k) · Cleared
ClearedPocket Breathalyzer. Connectables
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Connectables, LLC · DJZ Devices, Breath Trapping, Alcohol
Cleared on Feb 23, 2006 as substantially equivalent to K043188 (Q3 Innovations, LLC, 2005) after a 169-day review. Its family tree reaches back 2 generations to 2004. 8 later devices descend from it.
- Decided
- Feb 23, 2006
- Review
- 169 days
- Class
- Class I
- Product code
- DJZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K041334 (2004). 8 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 deviceK052448 Pocket Breathalyzer. ConnectablesConnectables, LLC · 2006
- Descendant · cites it directly · 3 of its ownK060761 Breathscan, Breath and Breath Check Alcohol DetectorsAkers Biosciences, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK062971 Breath Alcohol Check .02 and Breathscan .02 Detection SystemsAkers Biosciences, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK102225 Alco-Breath Tube, Checkpoint Breath Alcohol TestAlcopro, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK102338 Breathscn ProAkers Biosciences, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK093143 Mission Breath Alcohol DetectorACON Laboratories, Inc. · 2010 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K060761Breathscan, Breath and Breath Check Alcohol DetectorsAkers Biosciences, Inc. · 2006 · cites it directly3descendants
- K062971Breath Alcohol Check .02 and Breathscan .02 Detection SystemsAkers Biosciences, Inc. · 2006 · cites it directly1descendant
- K102225Alco-Breath Tube, Checkpoint Breath Alcohol TestAlcopro, Inc. · 2011 · 2 generations on0descendants
- K102338Breathscn ProAkers Biosciences, Inc. · 2011 · 2 generations on0descendants
- K093143Mission Breath Alcohol DetectorACON Laboratories, Inc. · 2010 · 2 generations on0descendants
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) | K052448 | Pocket Breathalyzer. Connectables | Connectables, LLC | 2006 | — |
| +1 | K060761 | Breathscan, Breath and Breath Check Alcohol Detectors | Akers Biosciences, Inc. | 2006 | — |
| +1 | K062971 | Breath Alcohol Check .02 and Breathscan .02 Detection Systems | Akers Biosciences, Inc. | 2006 | — |
| +2 | K102225 | Alco-Breath Tube, Checkpoint Breath Alcohol Test | Alcopro, Inc. | 2011 | — |
| +2 | K102338 | Breathscn Pro | Akers Biosciences, Inc. | 2011 | — |
| +2 | K093143 | Mission Breath Alcohol Detector | ACON Laboratories, Inc. | 2010 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 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…lassification Name: Device, breath trapping, alcohol, DJZ Common/Usual Name: Breath-alcohol test system 2. Equivalent legally marketed device: Alcohawk Precision, K043188 3. Indications for Use (intended use) : This device is intended to measure alcohol in the human breath. Measurements obtaine… | 2005 |
What descends from it? (8)
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 2 years and passes through 3 companies; a new generation was cleared every 1.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K060761 (Akers Biosciences, Inc., 2006) has gone furthest, with 3 descendants 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.
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 the human breath. Measurements obtained by this device are used as an aid in the detection of alcohol intoxication.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052448 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052448: Pocket Breathalyzer. Connectables.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052448
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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