510(k) Report

Devices descending from K940961

57 later devices reach Monoject Luer Adapter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K972527Phaseal, System for Sealed Handling of Chemotherapeutic AgentsQuality System Consulting199756—
+2K120384Protector, Injector, ConnectorBd Medical-Medical Surgical Systems201235—
+2K092782Injector Luer, Model N34, Injector Luer Lock, Model N35, Injector Luer Lock, N35C…Carmel Pharma Ab.200936—
+2K083152Equashield SystemPlastmed, Ltd.20099—
+2K053049Alaris Safety Male LuerCardinal Health, Alaris Products2006143
+2K980381Phaseal, Closed System Forhandling of Parenteral Drugs, Additional Administration…Carmel Pharma Ab.199849—
+3K223076BD Texium™ Closed Male LuerCare Fusion20231—
+3K132011Apoteca Dug Compounding Dosing Device,Apoteca I.V. Transfer SetAea Srl20140—
+3K123213BD Phaseal Closed System Transfer DeviceBecton, Dickinson & CO2013342
+3K121554Q-Flo Closed Male Luer ConnectorUs Fusion, LLC. Dba Truecare Biomedix-USA20120—
+3K101940Equashield System Protective PlusEquashield Medical, Ltd.20107—
+3K091389Equalshield Luer Lock Connector PairPlastmed, Ltd.20098—
+3K072759VIAL2BAGMedimop Medical Projects, Ltd.20072Class I
+3K071741Tevadaptor, Closed Drug Reconstitution and Transfer SystemMigada Plant2007111
+3K071108Texium SyringeCardinal Health, Alaris Products2007111
+3K060866Phaseal - Closed System for the Preparation and Administration of Parenteral DrugsCarmel Pharma Ab.200636—
+3K051669Tevadaptor Closed Drug Reconstitution and Transfer SystemMigada Plant2005131
+3K023747PhasealCarmel Pharma Ab.200238—
+4K222929ToxiSeal Vial Adapter with External BalloonEpic Medical Pte., Ltd.20242—
+4K231888BD Texium™ Needle-Free SyringeCare Fusion20230—
+4K192075ProSeal™ Closed System drug Transfer Device (CSTD)Epic Medical Pte., Ltd.20204—
+4K181221BD PhaSeal Optima Closed System Transfer DeviceBecton, Dickinson and Company201821
+4K172499NeoshieldJMS North America Corporation20180—
+4K150486HaloJ & J Solutions, Inc. D/B/A/ Corvida Medical201511
+4K141448Tevadaptor Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant20159—
+4K140730VIAL2BAG Direct ConnectMedimop Medical Projects, Ltd.201411
+4K140591BD Phaseal Closed System Transfer Device - InjectorBecton, Dickinson & CO201421
+4K132899Equashield Closed System Drug Transfer Device (CSTD)Equashield Medical, Ltd.20146—
+4K131549Chemolock, Chemolock PortIcu Medical, Inc.201310Class I
+4K130197BD Phaseal Closed System Transfer Device - P55Becton, Dickinson and Company2013191
+4K110023Infusion Adapter C100Carmel Pharma Ab.201137—
+5K250059BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O)Becton, Dickinson and Company20250—
+5K241476ToxiSeal™ Vial Adaptor with External Flip BalloonEpic Medical Pte., Ltd.20241—
+5K240171ProSeal™ Injector Plus (Model no. 421050)Epic Medical Pte., Ltd.20243—
+5K201422Arisure Closed System Drug Transfer Device (CSTD)Yukon Medical, LLC20211—
+5K201099BD PhaSeal Optima Closed System Drug Transfer DeviceBecton, Dickinson and Company202001
+5K192866Chemfort CSTDSimplivia Healthcare, Ltd.202031
+5K180489TEVADAPTOR Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant20181—
+5K180574Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo…J & J Solutions, Inc. D/B/A/ Corvida Medical20180—
+5K172631Arisure Dry SpikeYukon Medical20170—
+5K170706Equashield Closed System drug Transfer Device (CSTD)Equashield Medical, Ltd.20175—
+5K170680TEVADAPTOR Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant20170—
+5K170095Vial2Bag Direct ConnectMedimop Medical Project, Ltd.20170Class I
+6K251722ProSeal™ Transfer Injector (421120, 421130, 421140)Epic Medical Pte., Ltd.20250—
+6K253033Chemfort® 28-day 20 mm Vial Adaptor and 13 mm ConvertorSimplivia Healthcare, Ltd.20250—
+6K251411Chemfort Female Luer Lock AdaptorSimplivia Healthcare, Ltd.20250—
+6K240517ProSeal™ Vented Universal Vial AdaptorEpic Medical Pte., Ltd.20240—
+6K241735ProSeal™ In Line Pump Set (423850)Epic Medical Pte., Ltd.20240—
+6K241823ToxiSeal™ Vial AdaptorEpic Medical Pte., Ltd.20240—
+6K240433ProSeal™ Injection Site Extended Male Luer Lock (422140)Epic Medical Pte., Ltd.20240—
+6K231286Chemfort® Catheter AdaptorSimplivia Healthcare, Ltd.20230—
+6K221513Equashield Closed System Transfer DeviceEquashield Medical, Ltd.20230—
+6K201460Closed System Transfer DeviceShinva Ande Healthcare Apparatus Co., Ltd.20223—
+6K210707OnGuard2 Chemfort Closed Administration (CADM)Simplivia Healthcare, Ltd.20210—
+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—