510(k) Report

Devices descending from K201460

3 later devices reach Closed System Transfer Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241988ProSeal™ Closed System Bag AccessEpic Medical Pte., Ltd.20242—
+2K251340ProSeal™ Bag Spike with Additive Port (423370ST, 423370)Epic Medical Pte., Ltd.20250—
+2K243976ZeroClear™ Bag Access (423100)Epic Medical Pte., Ltd.20250—