510(k) Report

Devices descending from K052925

3 later devices reach SMARTPREP2 Centrifuge System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250518SMART M-CELL Bone Marrow Concentration SystemMiracell Co., Ltd.20260—
+1K250516SMART M-CELL PRP Concentration SystemMiracell Co., Ltd.20260—
+1K081345Axp Platform Marrow Xpress System Model 8-5137, 8-5138, 8-5139, 8-5140 (Primary)Thermogenesis Corp.20080—