510(k) Report

Devices descending from K934561

28 later devices reach One Time Vial Access Spike through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080989Universal Vial Access SpikeIcu Medical, Inc.2008131
+1K051930Drug Access SpikeMedegen Medical Manufacturing Services20050—
+1K013087Single Dose Dispensing Pin, Model 2201Alaris Medical Systems, Inc.200112—
+2K121182Vialok Non-VentedYukon Medical, LLC20121—
+2K081361Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXXIcu Medical, Inc.200812Class I
+2K071307Invirolink and Inviro Tip Blunt Cannulas, Model 130001, 130501, 140001, 140002, 140003Inviro Medical Devices, Inc.20082—
+2K041232Gettig Universal Vial Access PinGettig Pharmaceutical Instrument Co.20040—
+2K040634Robertsite Vial Adapter, Model 245700021Halkey-Roberts Corp.20045—
+3K173477ChemoCLAVE Cytotoxic Medication Preparation and Delivery SystemIcu Medical, Inc.201809
+3K131549Chemolock, Chemolock PortIcu Medical, Inc.201310Class I
+3K122265Vialok Single Vial Access Device VentedYukon Medical, LLC20120—
+3K083851Inviroblunt Cannula with and Without EZ Wings, Models 120522 and 120022Inviro Medical Devices, Inc.20091—
+3K072759VIAL2BAGMedimop Medical Projects, Ltd.20072Class I
+3K072511Swabable Vial Adapter 13MM, Swabable Vial Adapter 20MMMedimop Medical Projects, Ltd.20070—
+3K061143Robertsite StopcockHalkey-Roberts Corp.20060—
+4K202732SOL-CARE IV Bag Safety ConnectorSol-Millennium Medical Group20210—
+4K141448Tevadaptor Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant20159—
+4K140730VIAL2BAG Direct ConnectMedimop Medical Projects, Ltd.201411
+5K201422Arisure Closed System Drug Transfer Device (CSTD)Yukon Medical, LLC20211—
+5K192866Chemfort CSTDSimplivia Healthcare, Ltd.202031
+5K180489TEVADAPTOR Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant20181—
+5K170680TEVADAPTOR Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant20170—
+5K170095Vial2Bag Direct ConnectMedimop Medical Project, Ltd.20170Class I
+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—
+6K231286Chemfort® Catheter AdaptorSimplivia Healthcare, Ltd.20230—
+6K210707OnGuard2 Chemfort Closed Administration (CADM)Simplivia Healthcare, Ltd.20210—