510(k) Report

Devices descending from K201809

3 later devices reach AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232467CleanCart A, CleanCart C, AK 98 Hemodialysis MachineBaxter Healthcare Corporation20231Class I
+1K211035U9000 Plus UltrafilterBaxter Healthcare Corporation20210—
+2K250508AK 98 Dialysis Machine (955607)Vantive US Healthcare, LLC20250—