510(k) Report

Devices descending from K955235

153 later devices reach B-D Ultra Fine II, Micro Fine + Short Needle Insulin Syringe through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K250510Sure-Fine Insulin SyringesShina Med Corporation20250—
+5K252033Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with NeedleCMT Health PTE., Ltd.20250—
+5K243027Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27…Hangzhou Sightnovo Medical Technology Co., Ltd.20250—
+5K243936StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)Staclear, Inc.20251—
+5K243149Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)Congruence Medical Solutions, LLC20240—
+5K242099Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without NeedleSol-Millennium Medical, Inc.20240—
+5K233794Insulin SyringeSpm Medicare Pvt., Ltd.20240—
+5K231519Revital CadyRevital Healthcare (Epz) Limited20230—
+5K230372VitreJect SyringeOcuject, LLC20230—
+5K220713Sol-Guard Auto-disable SyringeSol-Millennium Medical, Inc.20230—
+5K212207Sterile Hypodermic Syringe for Single UseShandong Weigao Group Medical Polymer Co., Ltd.20230—
+5K222672Disposable Insulin SyringeHantech Medical Device Co., Ltd.20230—
+5K212635SofjecHwajin Medical Co., Ltd.20232—
+5K223334Sterile Hypodermic Needles for Single UseZhejiang Kindly Medical Devices Co., Ltd.20221—
+5K212846Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic…Jiangsu Jichun Medical Devices Co., Ltd.20220—
+5K212033Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin…Shandong Zhushi Pharmaceutical Group Co., Ltd.20220—
+5K210748Well-life TM Pen Needles, Well-life TM Safety Pen NeedlesW. L. Med Co., Ltd.20221—
+5K213811Sterile Hypodermic Syringes for Single UseBerpu Medical Technology Co., Ltd.20221—
+5K201044CHIRANA Insulin SyringesChirana T. Injecta20221—
+5K212226DR Safety Syringe, Sterile Hypodermic needle for Single useZhuhai DR Medical Instruments Co., Ltd.20210—
+5K211242Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic SyringesPromisemed Hangzhou Meditech Co., Ltd.20213—
+5K210712Verifine Mechanical Safety Insulin SyringePromisemed Hangzhou Meditech Co., Ltd.20210—
+5K202570Insulin Syringe, Insulin Syringe with Safety RetractableJiangsu Micsafe Medical Technology Co., Ltd.20212—
+5K201930Nanum SyringeNanum Company Co., Ltd.20210—
+5K201284Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile…Set Medikal Sanayi VE Ticaret Anonim Sirketi20202—
+5K191639TK Insulin Syringe with/without Saftey Retractable DeviceAnhui Tiankang Medical Technology Co., Ltd.20200—
+5K191644TK Safety NeedleAnhui Tiankang Medical Technology Co., Ltd.20203—
+5K193022Retractable Safety Insulin SyringeJiangsu Caina Medical Co.,Ltd20200—
+5K1827655cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial…Top Corporation20190—
+5K181374NRFit SyringeJiangsu Caina Medical Co.,Ltd20180—
+5K171131MHC Standard and NRFit Tip SyringesMazza Healthcare, LLC20171—
+5K152877SureFine Pen NeedleShina Med Corporation20161—
+5K141749Carefine Pen Needle Family Including Quintapoint and SuperpointFacet Technologies, LLC20140—
+5K140568Carefine Pen Needle with Quintapoint and SuperpointFacet Technologies, LLC20141—
+6K260855Profoject™ Safety Pen NeedlesCMT Health PTE., Ltd.20260—
+6K252279Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)Chirana T.Injecta,A.S.20260—
+6K251849StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)Staclear, Inc.20250—
+6K250658SureFine Pen NeedleShina Med Corporation20250—
+6K242434Insulin SyringesChirana T. Injecta20240—
+6K241856Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…Hlb Lifescience Co., Ltd.20241—
+6K231723Sterile Safety Hypodermic Needles for Single UseWepon Medical Technology Co., Ltd.20230—
+6K212857Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single UseJiangsu Zhiyu Medical Instrument Co, Ltd.20230—
+6K212764Medwell Technology Ltd Syringes, various sizesMedwell Technology, Ltd.20220—
+6K220603Disposable Medical Safety Hypodermic NeedleHantech Medical Device Co., Ltd.20220—
+6K220061Safety Insulin SyringesBerpu Medical Technology Co., Ltd.20221—
+6K213535Sterile Safety Hypodermic Needles for Single UseZhejiang Kangkang Medical-Devices Co., Ltd.20220—
+6K213560Verifine Safety Syringe with Fixed NeedlePromisemed Hangzhou Meditech Co., Ltd.20222—
+6K2102001 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-LockSet Medikal Sanayi VE Ticaret Anonim Sirketi20210—
+6K171144Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 BevelMedbio, LLC20170—
+7K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…Hlb Lifescience Co., Ltd.20260—
+7K230061Insulin SyringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.20230—
+7K231792VeriSafe Safety sterile syringesPromisemed Hangzhou Meditech Co., Ltd.20231—
+8K250192Verisafe Safety Retractable Insulin SyringesPromisemed Hangzhou Meditech Co., Ltd.20250—