510(k) Report

Devices descending from K970737

120 later devices reach B-D Ultra-Fine II Short 31G X 5/16 Pen Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K210712Verifine Mechanical Safety Insulin SyringePromisemed Hangzhou Meditech Co., Ltd.20210—
+6K202570Insulin Syringe, Insulin Syringe with Safety RetractableJiangsu Micsafe Medical Technology Co., Ltd.20212—
+6K2102001 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-LockSet Medikal Sanayi VE Ticaret Anonim Sirketi20210—
+6K191639TK Insulin Syringe with/without Saftey Retractable DeviceAnhui Tiankang Medical Technology Co., Ltd.20200—
+6K193022Retractable Safety Insulin SyringeJiangsu Caina Medical Co.,Ltd20200—
+6K152514Clickfine AutoProtect Pen NeedleYpsomed AG20157—
+6K150662Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)Ypsomed AG20150—
+7K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…Hlb Lifescience Co., Ltd.20260—
+7K251849StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)Staclear, Inc.20250—
+7K231792VeriSafe Safety sterile syringesPromisemed Hangzhou Meditech Co., Ltd.20231—
+7K220061Safety Insulin SyringesBerpu Medical Technology Co., Ltd.20221—
+7K210864Safety Pen NeedleSandstone Medical (Suzhou), Inc.20221—
+7K181447Safety insulin needle for single useBerpu Medical Technology Co., Ltd.20194—
+8K253622Safety Pen NeedleNingbo Medsun Medical Co., Ltd.20260—
+8K250192Verisafe Safety Retractable Insulin SyringesPromisemed Hangzhou Meditech Co., Ltd.20250—
+8K230061Insulin SyringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.20230—
+8K213183Safety Insulin Pen NeedlesZhejiang Kindly Medical Devices Co., Ltd.20220—
+8K212514Safety Pen Needle for Single Use, Insulin Pen NeedlesBerpu Medical Technology Co., Ltd.20220—
+8K192677Safety Insulin Pen NeedleJiangsu Caina Medical Co.,Ltd20201—
+9K221178Disposable Insulin Pen NeedleNingbo Medsun Medical Co., Ltd.20220—