Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DJZ — Predicate Candidate Screening
28 FDA 510(k) clearances under this product code; the 50 most recent screened below.
127 daysmedian FDA review time
252 days90th percentile
28clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K160613 | Soberlink Cellular Device and Sober Sky Web Portal | Soberlink Healthcare, LLC | 2016-07-14 | 133 | 0 |
| K123470 | PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE | Pas Systems International, Inc. | 2013-04-29 | 167 | 0 |
| K110614 | PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM | Seju Engineering Co., Ltd. | 2011-11-21 | 263 | 0 |
| K102225 | ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST | Alcopro, Inc. | 2011-04-06 | 240 | 0 |
| K102338 | BREATHSCN PRO | Akers Biosciences, Inc. | 2011-01-12 | 147 | 0 |
| K100879 | CONTRALCO | Contralco | 2010-08-04 | 127 | 0 |
| K093143 | MISSION BREATH ALCOHOL DETECTOR | ACON Laboratories, Inc. | 2010-01-28 | 115 | 1 |
| K091714 | ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579 | Skyfine Inc. Limited | 2009-11-18 | 161 | 0 |
| K090766 | LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER | Lifeloc Technologies, Inc. | 2009-07-23 | 122 | 0 |
| K082080 | ALCO TUBE PLUS | Alcotest Quebec | 2009-04-01 | 252 | 0 |
| K090067 | BACTRACK SELECT BREATHALYZER, MODEL S80 | Khn Solutions, LLC | 2009-03-24 | 74 | 0 |
| K083801 | BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70 | Khn Solutions, LLC | 2009-03-19 | 87 | 0 |
| K081855 | IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS) | Canada, Inc. | 2008-12-19 | 172 | 0 |
| K082086 | KEY RING ALCOHOL BREATHALYZER | The Ashley Collection, Inc. | 2008-12-19 | 149 | 0 |
| K080848 | ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR | Q3 Innovations, LLC | 2008-07-25 | 121 | 0 |
| K063443 | DRAEGER ALCOTEST 6510 | Drager Safety | 2008-03-11 | 483 | 0 |
| K072953 | REDLINE ALCOHOL BREATH TESTER | Redline Products (Pty) , Ltd. | 2008-01-07 | 81 | 0 |
| K071067 | BACTRACK LCD ALCOHOL DETECTOR | Khn Solutions, LLC | 2007-09-14 | 151 | 0 |
| K062545 | RMI LCD ALCOHOL DETECTOR | Resource Management International, LLC | 2007-04-09 | 222 | 0 |
| K062971 | BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEM | Akers Biosciences, Inc. | 2006-12-18 | 80 | 0 |
| K061922 | BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000 | Sentech Korea Corp. | 2006-10-30 | 115 | 0 |
| K060343 | BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000 | Sentech Korea Corp. | 2006-05-11 | 90 | 0 |
| K060761 | BREATHSCAN, BREATH AND BREATH CHECK ALCOHOL DETECTORS | Akers Biosciences, Inc. | 2006-04-28 | 38 | 0 |
| K052448 | POCKET BREATHALYZER. CONNECTABLES | Connectables, LLC | 2006-02-23 | 169 | 0 |
| K053332 | BREATH ALCOHOL TEST SYSTEM, MODEL AL 2500 | Sentech Korea Corp. | 2006-01-20 | 50 | 0 |
| K052804 | BREATHKEY MODEL G10/BREATHKEY MODEL G30X | Omega Point Systems, LLC | 2005-12-09 | 66 | 0 |
| K043188 | ALCOHAWK PRECISION | Q3 Innovations, LLC | 2005-02-09 | 84 | 0 |
| K041334 | ALCOMATE, MODEL CA2000 | Khn Solutions, LLC | 2004-08-11 | 84 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda