510(k) Report

Devices descending from K910793

8 later devices reach Reconstitution Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K973654Vial-Mate Reconstitution Device (2B8071)Baxter Healthcare Corp199771
+2K142600VIAL-MATE AdaptorBaxter Healthcare Corporation20146—
+3K201415Vial2Bag Advanced 20mm Admixture DeviceWest Pharmaceutical Services Az, Inc.202051
+4K252987ADRx™ Admixture DeviceEpic Medical Pte., Ltd.20260—
+4K230988Vial2Bag Advanced® 13mm Admixture DeviceWest Pharma. Services IL, Ltd.20231—
+4K212525Advcare Vial Direct to Bag (VDB) Needle-free Admixture DevicesAdvcare Medical20220—
+4K212445freeflex+ Transfer AdapterFresenius Kabi AG20220—
+5K240940Vial2Bag Advanced® 20mm Admixture DeviceWest Pharmaceutical Services, Inc.20240—