510(k) Report

Devices descending from K191653

4 later devices reach Freestyle Flex through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212773ARDO AlyssaArdo Medical AG20221—
+1K210759Solo, Swing MaxiMedela, LLC20211—
+2K232608Duo Hands-free Breast PumpMedela, LLC20240—
+2K230590ARDO BellisArdo Medical AG20230—