Atlas FDA

DJZ

28 FDA 510(k) clearances · Product code

127 daysmedian time to decision
252 days90th percentile
28clearances measured

FDA profile

Official device name
Devices, Breath Trapping, Alcohol
Device class
Class I (low risk)
Regulation
21 CFR 862.3050
Medical specialty
Clinical Toxicology
Adverse events (MAUDE)
1998: 2 · 2007: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Soberlink Cellular Device and Sober Sky Web Portal (K160613)Soberlink Healthcare, LLC2016-07-14
PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE (K123470)Pas Systems International, Inc.2013-04-29
PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM (K110614)Seju Engineering Co., Ltd.2011-11-21
ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST (K102225)Alcopro, Inc.2011-04-06
BREATHSCN PRO (K102338)Akers Biosciences, Inc.2011-01-12
CONTRALCO (K100879)Contralco2010-08-04
MISSION BREATH ALCOHOL DETECTOR (K093143)ACON Laboratories, Inc.2010-01-28
ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579 (K091714)Skyfine Inc. Limited2009-11-18
LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER (K090766)Lifeloc Technologies, Inc.2009-07-23
ALCO TUBE PLUS (K082080)Alcotest Quebec2009-04-01
BACTRACK SELECT BREATHALYZER, MODEL S80 (K090067)Khn Solutions, LLC2009-03-24
BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70 (K083801)Khn Solutions, LLC2009-03-19
IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS) (K081855)Canada, Inc.2008-12-19
KEY RING ALCOHOL BREATHALYZER (K082086)The Ashley Collection, Inc.2008-12-19
ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR (K080848)Q3 Innovations, LLC2008-07-25
DRAEGER ALCOTEST 6510 (K063443)Drager Safety2008-03-11
REDLINE ALCOHOL BREATH TESTER (K072953)Redline Products (Pty) , Ltd.2008-01-07
BACTRACK LCD ALCOHOL DETECTOR (K071067)Khn Solutions, LLC2007-09-14
RMI LCD ALCOHOL DETECTOR (K062545)Resource Management International, LLC2007-04-09
BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS (K062971)Akers Biosciences, Inc.2006-12-18
BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000 (K061922)Sentech Korea Corp.2006-10-30
BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000 (K060343)Sentech Korea Corp.2006-05-11
BREATHSCAN, BREATH AND BREATH CHECK ALCOHOL DETECTORS (K060761)Akers Biosciences, Inc.2006-04-28
POCKET BREATHALYZER. CONNECTABLES (K052448)Connectables, LLC2006-02-23
BREATH ALCOHOL TEST SYSTEM, MODEL AL 2500 (K053332)Sentech Korea Corp.2006-01-20
BREATHKEY MODEL G10/BREATHKEY MODEL G30X (K052804)Omega Point Systems, LLC2005-12-09
ALCOHAWK PRECISION (K043188)Q3 Innovations, LLC2005-02-09
ALCOMATE, MODEL CA2000 (K041334)Khn Solutions, LLC2004-08-11

Track DJZ automatically

Every clearance here is in the API, with alerts when new ones post.