510(k) Report

Devices descending from K133100

3 later devices reach Carefine Pen Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141749Carefine Pen Needle Family Including Quintapoint and SuperpointFacet Technologies, LLC20140—
+1K140568Carefine Pen Needle with Quintapoint and SuperpointFacet Technologies, LLC20141—
+2K171144Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 BevelMedbio, LLC20170—