510(k) Report

Devices descending from K053049

14 later devices reach Alaris Safety Male Luer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223076BD Texium™ Closed Male LuerCare Fusion20231—
+1K121554Q-Flo Closed Male Luer ConnectorUs Fusion, LLC. Dba Truecare Biomedix-USA20120—
+1K071108Texium SyringeCardinal Health, Alaris Products2007111
+2K231888BD Texium™ Needle-Free SyringeCare Fusion20230—
+2K083152Equashield SystemPlastmed, Ltd.20099—
+3K101940Equashield System Protective PlusEquashield Medical, Ltd.20107—
+3K091389Equalshield Luer Lock Connector PairPlastmed, Ltd.20098—
+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—