510(k) Report

Devices descending from K973654

7 later devices reach Vial-Mate Reconstitution Device (2B8071) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142600VIAL-MATE AdaptorBaxter Healthcare Corporation20146—
+2K201415Vial2Bag Advanced 20mm Admixture DeviceWest Pharmaceutical Services Az, Inc.202051
+3K252987ADRx™ Admixture DeviceEpic Medical Pte., Ltd.20260—
+3K230988Vial2Bag Advanced® 13mm Admixture DeviceWest Pharma. Services IL, Ltd.20231—
+3K212525Advcare Vial Direct to Bag (VDB) Needle-free Admixture DevicesAdvcare Medical20220—
+3K212445freeflex+ Transfer AdapterFresenius Kabi AG20220—
+4K240940Vial2Bag Advanced® 20mm Admixture DeviceWest Pharmaceutical Services, Inc.20240—