510(k) Report

Devices descending from K092686

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241037ABL90 FLEX PLUS SystemRadiometer Medicals Aps20250—
+1K200986OPTI® B-Lac CassetteOpti Medical Systems, Inc.20210—
+1K130144ABL90 FlexRadiometer Medical Aps201303
+1K122642ABL90 FlexRadiometer Medical Aps20120—
+1K120197ABL90 FlexRadiometer Medical Aps201263
+1K111897ABL90Radiometer Medical Aps201112
+2K123748ABL90 FlexRadiometer Medical Aps20130—
+2K122729ABL90 FlexRadiometer Medical Aps20125—
+3K131988ABL90 Flex AnalyzerRadiometer Medical Aps20133—
+4K160153ABL90 Flex PlusRadiometer Medical Aps201625
+5K252207ABL90 FLEX PLUS System, safeCLINITUBESRadiometer Medicals Aps20260—
+5K240998ABL90 FLEX PLUS SystemRadiometer Medicals Aps20240—