510(k) Report

Devices descending from K130197

19 later devices reach BD Phaseal Closed System Transfer Device - P55 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150486HaloJ & J Solutions, Inc. D/B/A/ Corvida Medical201511
+1K141448Tevadaptor Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant20159—
+1K132899Equashield Closed System Drug Transfer Device (CSTD)Equashield Medical, Ltd.20146—
+2K201422Arisure Closed System Drug Transfer Device (CSTD)Yukon Medical, LLC20211—
+2K192866Chemfort CSTDSimplivia Healthcare, Ltd.202031
+2K180489TEVADAPTOR Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant20181—
+2K180574Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo…J & J Solutions, Inc. D/B/A/ Corvida Medical20180—
+2K170706Equashield Closed System drug Transfer Device (CSTD)Equashield Medical, Ltd.20175—
+2K170680TEVADAPTOR Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant20170—
+3K253033Chemfort® 28-day 20 mm Vial Adaptor and 13 mm ConvertorSimplivia Healthcare, Ltd.20250—
+3K251411Chemfort Female Luer Lock AdaptorSimplivia Healthcare, Ltd.20250—
+3K240517ProSeal™ Vented Universal Vial AdaptorEpic Medical Pte., Ltd.20240—
+3K231286Chemfort® Catheter AdaptorSimplivia Healthcare, Ltd.20230—
+3K221513Equashield Closed System Transfer DeviceEquashield Medical, Ltd.20230—
+3K201460Closed System Transfer DeviceShinva Ande Healthcare Apparatus Co., Ltd.20223—
+3K210707OnGuard2 Chemfort Closed Administration (CADM)Simplivia Healthcare, Ltd.20210—
+4K241988ProSeal™ Closed System Bag AccessEpic Medical Pte., Ltd.20242—
+5K251340ProSeal™ Bag Spike with Additive Port (423370ST, 423370)Epic Medical Pte., Ltd.20250—
+5K243976ZeroClear™ Bag Access (423100)Epic Medical Pte., Ltd.20250—