510(k) Report

Devices descending from K954064

17 later devices reach Becton Dickinson Syringse through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071108Texium SyringeCardinal Health, Alaris Products2007111
+1K982966Disetronic PenDisetronic Medical Systems19984—
+2K231888BD Texium™ Needle-Free SyringeCare Fusion20230—
+2K083457TactipenHaselmeier GmbH20090—
+2K083152Equashield SystemPlastmed, Ltd.20099—
+2K070100Haselmeier PenHaselmeier Sarl20072—
+2K993666Disetronic Pen P100Disetronic Medical Systems19990—
+3K101940Equashield System Protective PlusEquashield Medical, Ltd.20107—
+3K091389Equalshield Luer Lock Connector PairPlastmed, Ltd.20098—
+3K082616Haselmeier Pen 8Haselmeier GmbH20080—
+4K132899Equashield Closed System Drug Transfer Device (CSTD)Equashield Medical, Ltd.20146—
+5K170706Equashield Closed System drug Transfer Device (CSTD)Equashield Medical, Ltd.20175—
+6K221513Equashield Closed System Transfer DeviceEquashield Medical, Ltd.20230—
+6K201460Closed System Transfer DeviceShinva Ande Healthcare Apparatus Co., Ltd.20223—
+7K241988ProSeal™ Closed System Bag AccessEpic Medical Pte., Ltd.20242—
+8K251340ProSeal™ Bag Spike with Additive Port (423370ST, 423370)Epic Medical Pte., Ltd.20250—
+8K243976ZeroClear™ Bag Access (423100)Epic Medical Pte., Ltd.20250—