510(k) Report

Devices descending from K131549

10 later devices reach Chemolock, Chemolock Port through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141448Tevadaptor Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant20159—
+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—
+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—
+3K210707OnGuard2 Chemfort Closed Administration (CADM)Simplivia Healthcare, Ltd.20210—