510(k) Report

Devices descending from K090111

16 later devices reach Flexpen Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173479NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)Novo Nordisk, Inc.20181—
+1K133738Novofine Plus 32G 4 MMNovo Nordisk, Inc.20142—
+1K133100Carefine Pen NeedleFacet Technologies20143—
+1K113186Sterile Insulin Pen NeedleShina Corp.20124—
+1K093109Novotwist Needle, Models 30G * 8MM (1/3) 32 G Tip * 5 MM (1/5')Novo Nordisk, Inc.20104—
+2K210748Well-life TM Pen Needles, Well-life TM Safety Pen NeedlesW. L. Med Co., Ltd.20221—
+2K210258NovoFineNovo Nordisk, Inc.20210—
+2K202005NovoFine Plus 32G Tip x 4 mmNovo Nordisk, Inc.20201—
+2K152877SureFine Pen NeedleShina Med Corporation20161—
+2K141749Carefine Pen Needle Family Including Quintapoint and SuperpointFacet Technologies, LLC20140—
+2K140568Carefine Pen Needle with Quintapoint and SuperpointFacet Technologies, LLC20141—
+2K120191Push-on Needle 30GX8MMScandinavian Health Limited20120—
+3K260855Profoject™ Safety Pen NeedlesCMT Health PTE., Ltd.20260—
+3K250658SureFine Pen NeedleShina Med Corporation20250—
+3K231255NovoFine® PlusNovo Nordisk, Inc.20230—
+3K171144Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 BevelMedbio, LLC20170—