510(k) Report

Devices descending from K061285

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223088BD SmartSite™ Needle-Free ConnectorCare Fusion20230—
+1K103562Centurion Pressure Injectable Extension SetCenturion Medical Products Corporation201111
+1K100576High Pressure Sets-400 PsiIcu Medical, Inc.201008
+1K090134Intravenous Power Injector Extension SetC.R. Bard, Inc.20091—
+2K141285Busse Extension SetBusse Hospital Disposables20150—
+2K093489IN Vision-Plus Nano with Neutral Advantage TechnologyRymed Technologies, Inc.201001