510(k) Report

Devices descending from K063466

11 later devices reach Top Fine through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160575CareSens Pen Needle, Softip Pen NeedleYidobio, Inc.20160—
+1K100812Ulticare Disposable Pen NeedlesUltimed, Inc.20109—
+2K133100Carefine Pen NeedleFacet Technologies20143—
+2K113186Sterile Insulin Pen NeedleShina Corp.20124—
+3K210748Well-life TM Pen Needles, Well-life TM Safety Pen NeedlesW. L. Med Co., Ltd.20221—
+3K152877SureFine Pen NeedleShina Med Corporation20161—
+3K141749Carefine Pen Needle Family Including Quintapoint and SuperpointFacet Technologies, LLC20140—
+3K140568Carefine Pen Needle with Quintapoint and SuperpointFacet Technologies, LLC20141—
+4K260855Profoject™ Safety Pen NeedlesCMT Health PTE., Ltd.20260—
+4K250658SureFine Pen NeedleShina Med Corporation20250—
+4K171144Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 BevelMedbio, LLC20170—