510(k) Report

Devices descending from K041334

23 later devices reach Alcomate, Model CA2000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081855Impair Aware Alcohol Level Indication System (Alis)Canada, Inc.20080—
+1K071067Bactrack LCD Alcohol DetectorKhn Solutions, LLC20070—
+1K062545Rmi LCD Alcohol DetectorResource Management International, LLC20070—
+1K061922Breath Alcohol Test System, Model AL-5000Sentech Korea Corp.20061—
+1K060343Breath Alcohol Test System, Model AL-6000Sentech Korea Corp.20060—
+1K052804Breathkey Model G10/Breathkey Model G30XOmega Point Systems, LLC20052—
+1K043188Alcohawk PrecisionQ3 Innovations, LLC200515—
+2K083801Bactrack Select Breathalyzer, Models S30, S50, S70Khn Solutions, LLC20090—
+2K080848Alcohawk Model PT500 Digital Alcohol DetectorQ3 Innovations, LLC20085—
+2K063443Draeger Alcotest 6510Drager Safety20081—
+2K052448Pocket Breathalyzer. ConnectablesConnectables, LLC20068—
+3K123470Pas Alcovisor Mars, Pas Alcovisor SatellitePas Systems International, Inc.20131—
+3K091714Alcodigital Breathalyzer, Model AT576, AT577, AT578, AT579Skyfine Inc. Limited20090—
+3K090766Lifeguard Backtrack B90 Breath Alcohol TesterLifeloc Technologies, Inc.20090—
+3K090067Bactrack Select Breathalyzer, Model S80Khn Solutions, LLC20090—
+3K082086Key Ring Alcohol BreathalyzerThe Ashley Collection, Inc.20080—
+3K062971Breath Alcohol Check .02 and Breathscan .02 Detection SystemsAkers Biosciences, Inc.20061—
+3K060761Breathscan, Breath and Breath Check Alcohol DetectorsAkers Biosciences, Inc.20063—
+4K160613Soberlink Cellular Device and Sober Sky Web PortalSoberlink Healthcare, LLC20160—
+4K102225Alco-Breath Tube, Checkpoint Breath Alcohol TestAlcopro, Inc.20110—
+4K102338Breathscn ProAkers Biosciences, Inc.20110—
+4K093143Mission Breath Alcohol DetectorACON Laboratories, Inc.201001
+4K082080Alco Tube PlusAlcotest Quebec20090—