510(k) Report

Devices descending from K002403

37 later devices reach Novofine 31 Disposable Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053470Novofine 32G TipNovo Nordisk, Inc.200518—
+1K050106Novofine Autocover 30G X 8MMNovo Nordisk, Inc.200534—
+1K021197Sureone Insulin Syringe, 31 Gauge X 5/16Hosuk Co., Ltd.2002010
+2K151311Safe Block Pen NeedleArtsana S.P.A201611—
+2K110527K-Pack Surshield Needle, Hypodermic Needle for Single UseTerumo Europe N.V.20113—
+2K093109Novotwist Needle, Models 30G * 8MM (1/3) 32 G Tip * 5 MM (1/5')Novo Nordisk, Inc.20104—
+2K090111Flexpen NeedleNovo Nordisk, Inc.201016—
+2K062500Flexpen NeedleNovo Nordisk, Inc.200617—
+3K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.20260—
+3K173479NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)Novo Nordisk, Inc.20181—
+3K161950Common Type Insulin Pen Needle, Safety Type Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20179—
+3K133738Novofine Plus 32G 4 MMNovo Nordisk, Inc.20142—
+3K133100Carefine Pen NeedleFacet Technologies20143—
+3K120191Push-on Needle 30GX8MMScandinavian Health Limited20120—
+3K113186Sterile Insulin Pen NeedleShina Corp.20124—
+3K11179727 G X 1/2 K-Pack Surshield NeedleTerumo Europe N.V.20112—
+4K24330927G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)Terumo Europe N.V.20250—
+4K242632Verifine® Pen NeedlesPromisemed Hangzhou Meditech Co., Ltd.20240—
+4K223353DropSafeTM SicuraTMPikdare Spa20220—
+4K210748Well-life TM Pen Needles, Well-life TM Safety Pen NeedlesW. L. Med Co., Ltd.20221—
+4K210059Promisemed Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20211—
+4K210258NovoFineNovo Nordisk, Inc.20210—
+4K210065Verifine Safety Type Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20210—
+4K193422Easydrip Pen Needle, Easydrip Plus Pen NeedleSandstone Medical (Suzhou), Inc.20211—
+4K202681Promisemed Covered Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20200—
+4K202005NovoFine Plus 32G Tip x 4 mmNovo Nordisk, Inc.20201—
+4K191853Dual-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20191—
+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—
+5K252908Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle…Sandstone Medical (Suzhou), Inc.20260—
+5K250658SureFine Pen NeedleShina Med Corporation20250—
+5K231255NovoFine® PlusNovo Nordisk, Inc.20230—
+5K222739Disposable Insulin Pen NeedleHantech Medical Device Co., Ltd.20230—
+5K202682Promisemed Triple Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20200—
+5K171144Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 BevelMedbio, LLC20170—