510(k) Report

Devices descending from K050869

18 later devices reach Modification to ABL800 Flex through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170882ABL90 Flex, ABL90 Flex PlusRadiometer Medical Aps20170—
+1K132691ABL90 FlexRadiometer Medical Aps20143—
+1K092686ABL90 Flex SeriesRadiometer Medical Aps20101210
+1K051804ABL80 Flex AnalyzerSendx Medical, Inc.200524
+2K241037ABL90 FLEX PLUS SystemRadiometer Medicals Aps20250—
+2K200986OPTI® B-Lac CassetteOpti Medical Systems, Inc.20210—
+2K160153ABL90 Flex PlusRadiometer Medical Aps201625
+2K130144ABL90 FlexRadiometer Medical Aps201303
+2K122642ABL90 FlexRadiometer Medical Aps20120—
+2K120197ABL90 FlexRadiometer Medical Aps201263
+2K111897ABL90Radiometer Medical Aps201112
+2K080370Abl 80 CO-OX SystemSendx Medical, Inc.200814
+3K252207ABL90 FLEX PLUS System, safeCLINITUBESRadiometer Medicals Aps20260—
+3K240998ABL90 FLEX PLUS SystemRadiometer Medicals Aps20240—
+3K151856ABL80 FLEX CO-OX with AQURE connectivitySendx Medical, Inc.201503
+3K123748ABL90 FlexRadiometer Medical Aps20130—
+3K122729ABL90 FlexRadiometer Medical Aps20125—
+4K131988ABL90 Flex AnalyzerRadiometer Medical Aps20133—