FDA product code DJZ: Devices, Breath Trapping, Alcohol
DJZ is the FDA product code for devices, breath trapping, alcohol. It is a Class I device, regulated under 21 CFR 862.3050 and reviewed by the Clinical Toxicology panel. FDA has cleared 28 510(k) submissions under DJZ, from 20 different applicants. The average 510(k) review took 144 days (median 124). FDA has posted 3 recalls for DJZ devices.
Classification
| Field | Value |
|---|---|
| Device name | Devices, Breath Trapping, Alcohol |
| Device class | Class I |
| Regulation | 21 CFR 862.3050 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DJZ clearance
Top DJZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Khn Solutions, LLC | 4 | 2009-03-24 |
| Akers Biosciences, Inc. | 3 | 2011-01-12 |
| Sentech Korea Corp. | 3 | 2006-10-30 |
| Q3 Innovations, LLC | 2 | 2008-07-25 |
| Soberlink Healthcare, LLC | 1 | 2016-07-14 |
15 more applicants have DJZ clearances. See the full list in Caduvo.
Most recent DJZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K160613 | Soberlink Healthcare, LLC | Soberlink Cellular Device and Sober Sky Web Portal | 2016-07-14 | 133 |
| K123470 | Pas Systems International, Inc. | PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE | 2013-04-29 | 167 |
| K110614 | Seju Engineering Co., Ltd. | PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM | 2011-11-21 | 263 |
| K102225 | Alcopro, Inc. | ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST | 2011-04-06 | 240 |
| K102338 | Akers Biosciences, Inc. | BREATHSCN PRO | 2011-01-12 | 147 |
Recalls for DJZ devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-06-17.
Frequently asked questions
What is FDA product code DJZ?
DJZ is the FDA product code for devices, breath trapping, alcohol. It is a Class I device, regulated under 21 CFR 862.3050 and reviewed by the Clinical Toxicology panel.
What device class is DJZ?
Class I, regulation 21 CFR 862.3050. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DJZ?
Across 28 cleared submissions the average was 144 days from receipt to decision (median 124).
Which companies have the most DJZ clearances?
Khn Solutions, LLC (4); Akers Biosciences, Inc. (3); Sentech Korea Corp. (3); Q3 Innovations, LLC (2); Soberlink Healthcare, LLC (1).
Have DJZ devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2015-06-17.
Next steps
- Run an FDA pathway report with predicate devices for product code DJZ
- Run a recall and safety report across every DJZ manufacturer
- Watch product code DJZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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