510(k) Report

Devices descending from K052561

17 later devices reach Terumo Micro Tapered Pen Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140516Terumo Pen Injector Needle 34Kofu Factory of Terumo Corp.20144—
+1K063466Top FineDaejin Tech Medical Manufacturing Co., Ltd.200711—
+2K250700Pen Injector Needle 32.5Terumo Corporation20250—
+2K192082Droplet Pen Needle 34GHtl-Strefa S.A20202—
+2K160575CareSens Pen Needle, Softip Pen NeedleYidobio, Inc.20160—
+2K100812Ulticare Disposable Pen NeedlesUltimed, Inc.20109—
+3K203792Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needlePikdare Spa20230—
+3K202340Droplet Pen Needle 30G & 33GHtl-Strefa S.A20200—
+3K133100Carefine Pen NeedleFacet Technologies20143—
+3K113186Sterile Insulin Pen NeedleShina Corp.20124—
+4K210748Well-life TM Pen Needles, Well-life TM Safety Pen NeedlesW. L. Med Co., Ltd.20221—
+4K152877SureFine Pen NeedleShina Med Corporation20161—
+4K141749Carefine Pen Needle Family Including Quintapoint and SuperpointFacet Technologies, LLC20140—
+4K140568Carefine Pen Needle with Quintapoint and SuperpointFacet Technologies, LLC20141—
+5K260855Profoject™ Safety Pen NeedlesCMT Health PTE., Ltd.20260—
+5K250658SureFine Pen NeedleShina Med Corporation20250—
+5K171144Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 BevelMedbio, LLC20170—