510(k) Report

Devices descending from K131988

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160153ABL90 Flex PlusRadiometer Medical Aps201625
+2K252207ABL90 FLEX PLUS System, safeCLINITUBESRadiometer Medicals Aps20260—
+2K240998ABL90 FLEX PLUS SystemRadiometer Medicals Aps20240—