510(k) Report

Devices descending from K120197

6 later devices reach ABL90 Flex through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130144ABL90 FlexRadiometer Medical Aps201303
+1K122729ABL90 FlexRadiometer Medical Aps20125—
+2K131988ABL90 Flex AnalyzerRadiometer Medical Aps20133—
+3K160153ABL90 Flex PlusRadiometer Medical Aps201625
+4K252207ABL90 FLEX PLUS System, safeCLINITUBESRadiometer Medicals Aps20260—
+4K240998ABL90 FLEX PLUS SystemRadiometer Medicals Aps20240—