510(k) Report

Devices descending from K991430

7 later devices reach Smartprep Centrifuge System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052925SMARTPREP2 Centrifuge SystemHarvest Technologies, Corp.200632
+1K030340Autologel Process Centrifuge, Model B4360 (100-103, 100-129)Cytomedix20030—
+1K021902Magellan Autologus Platelet Separator, MAG100, Magellan Autologous Platelet Separator…Medtronic Vascular20021—
+2K250518SMART M-CELL Bone Marrow Concentration SystemMiracell Co., Ltd.20260—
+2K250516SMART M-CELL PRP Concentration SystemMiracell Co., Ltd.20260—
+2K081345Axp Platform Marrow Xpress System Model 8-5137, 8-5138, 8-5139, 8-5140 (Primary)Thermogenesis Corp.20080—
+2K042473Cobe Angel Whole Blood Separation SystemCobe Cardiovascular, Inc.20040—