510(k) Report

Devices descending from K041874

29 later devices reach ABL800 Flex through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200492i-STAT CG4+ Cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20200—
+1K142898ABL800 FLEX with AQURE connectivityRadiometer Medical Aps201533
+1K092686ABL90 Flex SeriesRadiometer Medical Aps20101210
+1K051968ABL8X7 FlexRadiometer Medical Aps200604
+1K050869Modification to ABL800 FlexRadiometer Medical Aps2005181
+1K043218ABL800 Flex with Flexq Module, Model ABL8XXRadiometer Medical Aps200543
+2K241037ABL90 FLEX PLUS SystemRadiometer Medicals Aps20250—
+2K200986OPTI® B-Lac CassetteOpti Medical Systems, Inc.20210—
+2K170882ABL90 Flex, ABL90 Flex PlusRadiometer Medical Aps20170—
+2K160402GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)Instrumentation Laboratory CO20162—
+2K151639ABL80 FLEX and ABL80 FLEX CO-OXSendx Medical, Inc.20150—
+2K132691ABL90 FlexRadiometer Medical Aps20143—
+2K130144ABL90 FlexRadiometer Medical Aps201303
+2K122642ABL90 FlexRadiometer Medical Aps20120—
+2K120197ABL90 FlexRadiometer Medical Aps201263
+2K111897ABL90Radiometer Medical Aps201112
+2K073537Neonatal Bilirubin on Rapidlab Models 1245 and 1265Siemens Medical Solutions Diagnostics200817
+2K051804ABL80 Flex AnalyzerSendx Medical, Inc.200524
+3K203790GEM Premier 5000Instrumentation Laboratory CO2021125
+3K160153ABL90 Flex PlusRadiometer Medical Aps201625
+3K123748ABL90 FlexRadiometer Medical Aps20130—
+3K122729ABL90 FlexRadiometer Medical Aps20125—
+3K110277Rapidpoint 405 Neonatal BilirubinSiemens Healthcare Diagnostics201105
+3K080370Abl 80 CO-OX SystemSendx Medical, Inc.200814
+4K252207ABL90 FLEX PLUS System, safeCLINITUBESRadiometer Medicals Aps20260—
+4K240998ABL90 FLEX PLUS SystemRadiometer Medicals Aps20240—
+4K223608GEM Premier 7000 with IQM3Instrumentation Laboratory Company202302
+4K151856ABL80 FLEX CO-OX with AQURE connectivitySendx Medical, Inc.201503
+4K131988ABL90 Flex AnalyzerRadiometer Medical Aps20133—