510(k) Report

Devices descending from K960280

20 later devices reach Ivac Needle Free Valve Administration Sets through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112073Infusite Needleless Acces Device (Sterile, Bulk Non-Sterile) and Infusite Needleless…Rx Devices, LLC20120—
+1K071400Smartsite StopcockCardinal Health, Alaris Products20070—
+1K061285Smartsite Needle Free Valve Administration SetsCardinal Health, Alaris Products200662
+1K970485Smartsite Access PinIvac Medical Systems1997113
+2K233021BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access DeviceCare Fusion20240—
+2K223088BD SmartSite™ Needle-Free ConnectorCare Fusion20230—
+2K103562Centurion Pressure Injectable Extension SetCenturion Medical Products Corporation201111
+2K100576High Pressure Sets-400 PsiIcu Medical, Inc.201008
+2K090134Intravenous Power Injector Extension SetC.R. Bard, Inc.20091—
+2K052790Smartsite Vented Vial Access Device, Model TBDCardinal Health, Alaris Products20055—
+2K002689Swabsite Swabbable Valve, Model 245000Quest Medical, Inc.20013—
+3K151963SmartSite Vented Vial Access DeviceYukon Medical, LLC20151—
+3K141285Busse Extension SetBusse Hospital Disposables20150—
+3K132863Smartsite VialshieldYukon Medical, LLC20131—
+3K120548Hlic Needle-Less ValveHealth Line International Corporation20120—
+3K093489IN Vision-Plus Nano with Neutral Advantage TechnologyRymed Technologies, Inc.201001
+3K072511Swabable Vial Adapter 13MM, Swabable Vial Adapter 20MMMedimop Medical Projects, Ltd.20070—
+3K061143Robertsite StopcockHalkey-Roberts Corp.20060—
+4K243486SmartSiteTM Vented Vial Access DeviceYukon Medical, LLC20240—
+4K172884Arisure Closed Vial AdapterYukon Medical20170—