510(k) Report

Devices descending from K100812

9 later devices reach Ulticare Disposable Pen Needles through their predicates, nearest generation first.

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