510(k) Report

Devices descending from K972527

56 later devices reach Phaseal, System for Sealed Handling of Chemotherapeutic Agents through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120384Protector, Injector, ConnectorBd Medical-Medical Surgical Systems201235—
+1K092782Injector Luer, Model N34, Injector Luer Lock, Model N35, Injector Luer Lock, N35C…Carmel Pharma Ab.200936—
+1K083152Equashield SystemPlastmed, Ltd.20099—
+1K053049Alaris Safety Male LuerCardinal Health, Alaris Products2006143
+1K980381Phaseal, Closed System Forhandling of Parenteral Drugs, Additional Administration…Carmel Pharma Ab.199849—
+2K223076BD Texium™ Closed Male LuerCare Fusion20231—
+2K132011Apoteca Dug Compounding Dosing Device,Apoteca I.V. Transfer SetAea Srl20140—
+2K123213BD Phaseal Closed System Transfer DeviceBecton, Dickinson & CO2013342
+2K121554Q-Flo Closed Male Luer ConnectorUs Fusion, LLC. Dba Truecare Biomedix-USA20120—
+2K101940Equashield System Protective PlusEquashield Medical, Ltd.20107—
+2K091389Equalshield Luer Lock Connector PairPlastmed, Ltd.20098—
+2K072759VIAL2BAGMedimop Medical Projects, Ltd.20072Class I
+2K071741Tevadaptor, Closed Drug Reconstitution and Transfer SystemMigada Plant2007111
+2K071108Texium SyringeCardinal Health, Alaris Products2007111
+2K060866Phaseal - Closed System for the Preparation and Administration of Parenteral DrugsCarmel Pharma Ab.200636—
+2K051669Tevadaptor Closed Drug Reconstitution and Transfer SystemMigada Plant2005131
+2K023747PhasealCarmel Pharma Ab.200238—
+3K222929ToxiSeal Vial Adapter with External BalloonEpic Medical Pte., Ltd.20242—
+3K231888BD Texium™ Needle-Free SyringeCare Fusion20230—
+3K192075ProSeal™ Closed System drug Transfer Device (CSTD)Epic Medical Pte., Ltd.20204—
+3K181221BD PhaSeal Optima Closed System Transfer DeviceBecton, Dickinson and Company201821
+3K172499NeoshieldJMS North America Corporation20180—
+3K150486HaloJ & J Solutions, Inc. D/B/A/ Corvida Medical201511
+3K141448Tevadaptor Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant20159—
+3K140730VIAL2BAG Direct ConnectMedimop Medical Projects, Ltd.201411
+3K140591BD Phaseal Closed System Transfer Device - InjectorBecton, Dickinson & CO201421
+3K132899Equashield Closed System Drug Transfer Device (CSTD)Equashield Medical, Ltd.20146—
+3K131549Chemolock, Chemolock PortIcu Medical, Inc.201310Class I
+3K130197BD Phaseal Closed System Transfer Device - P55Becton, Dickinson and Company2013191
+3K110023Infusion Adapter C100Carmel Pharma Ab.201137—
+4K250059BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O)Becton, Dickinson and Company20250—
+4K241476ToxiSeal™ Vial Adaptor with External Flip BalloonEpic Medical Pte., Ltd.20241—
+4K240171ProSeal™ Injector Plus (Model no. 421050)Epic Medical Pte., Ltd.20243—
+4K201422Arisure Closed System Drug Transfer Device (CSTD)Yukon Medical, LLC20211—
+4K201099BD PhaSeal Optima Closed System Drug Transfer DeviceBecton, Dickinson and Company202001
+4K192866Chemfort CSTDSimplivia Healthcare, Ltd.202031
+4K180489TEVADAPTOR Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant20181—
+4K180574Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo…J & J Solutions, Inc. D/B/A/ Corvida Medical20180—
+4K172631Arisure Dry SpikeYukon Medical20170—
+4K170706Equashield Closed System drug Transfer Device (CSTD)Equashield Medical, Ltd.20175—
+4K170680TEVADAPTOR Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant20170—
+4K170095Vial2Bag Direct ConnectMedimop Medical Project, Ltd.20170Class I
+5K251722ProSeal™ Transfer Injector (421120, 421130, 421140)Epic Medical Pte., Ltd.20250—
+5K253033Chemfort® 28-day 20 mm Vial Adaptor and 13 mm ConvertorSimplivia Healthcare, Ltd.20250—
+5K251411Chemfort Female Luer Lock AdaptorSimplivia Healthcare, Ltd.20250—
+5K240517ProSeal™ Vented Universal Vial AdaptorEpic Medical Pte., Ltd.20240—
+5K241735ProSeal™ In Line Pump Set (423850)Epic Medical Pte., Ltd.20240—
+5K241823ToxiSeal™ Vial AdaptorEpic Medical Pte., Ltd.20240—
+5K240433ProSeal™ Injection Site Extended Male Luer Lock (422140)Epic Medical Pte., Ltd.20240—
+5K231286Chemfort® Catheter AdaptorSimplivia Healthcare, Ltd.20230—
+5K221513Equashield Closed System Transfer DeviceEquashield Medical, Ltd.20230—
+5K201460Closed System Transfer DeviceShinva Ande Healthcare Apparatus Co., Ltd.20223—
+5K210707OnGuard2 Chemfort Closed Administration (CADM)Simplivia Healthcare, Ltd.20210—
+6K241988ProSeal™ Closed System Bag AccessEpic Medical Pte., Ltd.20242—
+7K251340ProSeal™ Bag Spike with Additive Port (423370ST, 423370)Epic Medical Pte., Ltd.20250—
+7K243976ZeroClear™ Bag Access (423100)Epic Medical Pte., Ltd.20250—