510(k) Report

Devices descending from K992802

84 later devices reach Terumo U-100 Insulin Syringe through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081547Bio-Med Soft Insulin Syringe: Models 1CC, 0.5CC, 0.3CCBio-Med USA, Inc.20080—
+1K071630Terumo 31G Thinpro Insulin SyringeTerumo Medical Corp.200782—
+2K160589Certa Dose PD Epinephrine 1mg/mL IM/SC SyringeCerta Dose, Inc.20170—
+2K090929Sterile Hypodermic Syringe and Needle for Single Use, Sterile Insuling Syringe for…Shanghai Double Dove Industrial Co., Ltd.20091—
+2K072739Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd.200878—
+3K210991Disposable Sterile Syringe, Disposable Sterile Syringe with NeedleGuangdong Antmed Co., Ltd.20210—
+3K180417Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single…Berpu Medical Technology Co., Ltd.201812—
+3K172938Disposable Sterile NeedleJiangsu Caina Medical Co.,Ltd20180—
+3K163161Sterile Single-use Syringe with NeedleJiangxi Hongda Medical Equipment Group, Ltd.20179—
+3K163162Sterile Hypodermic Safety Syringes for Single UseJiangxi Hongda Medical Equipment Group, Ltd.20170—
+3K162180Disposable Insulin SyringeBerpu Medical Technology Co., Ltd.20165—
+3K151949Disposable Insulin SyringeJiangyin Caina Technology Co., Ltd.20156—
+3K124037Jung Rim Single Use Hypodermic Syringe with NeedleJung Rim Medical Industrial Co., Ltd.20130—
+3K112057KDL Syringes and NeedleShanghai Kindly Enterprise Dev. Group Co.,201131—
+3K110697Tiger Syringes and NeedlesTiger Medical Products, Ltd.20110—
+3K110853VR Medical Enteral Oral SyringeVr Medical20110—
+3K110421Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd.201136—
+4K232165Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single…Berpu Medical Technology Co., Ltd.20240—
+4K233037Sterile Hypodermic Needles for Single UseZhejiang Kindly Medical Device Co., Ltd.20230—
+4K221777Disposable Sterile SyringeWeihai Shengjie Medical Technology Co., Ltd.20230—
+4K231729Sterile syringes for single use with/without needleWepon Medical Technology Co., Ltd.20230—
+4K231720Sterile Hypodermic Needles for Single UseWepon Medical Technology Co., Ltd.20230—
+4K223453Insulin SyringePromisemed Hangzhou Meditech Co., Ltd.20232—
+4K203211Insulin syringe with integrated needle DLDlp Medical Products, Corp.20230—
+4K221045Insulin Syringes without needleBerpu Medical Technology Co., Ltd.20220—
+4K221079Sterile Hypodermic Syringes for Single UseSichuan Prius Biotechnology Co., Ltd.20221—
+4K221066Sterile Hypodermic Needles for Single UseSichuan Prius Biotechnology Co., Ltd.20220—
+4K221080Sterile Safety Hypodermic Needles for Single UseSichuan Prius Biotechnology Co., Ltd.20220—
+4K211482Disposable Syringe with NeedleShandong Qinkai Medical Industry Co., Ltd.20220—
+4K211214Sterile Hypodermic Needles for Single UseAzur Medical Company, Inc.20214—
+4K211211Sterile syringes for single use with/without needleAzur Medical Company, Inc.20211—
+4K211728Sterile hypodermic syringes for single useJiangsu Kangyou Medical Instrument Co., Ltd.20210—
+4K210232Sterile Hypodermic Needles for Single UseZhejiang Kangkang Medical-Devices Co., Ltd.20210—
+4K210227Sterile syringe for single use with/without needleZhejiang Kangkang Medical-Devices Co., Ltd.20212—
+4K193273Insulin SyringePromisemed Hangzhou Meditech Co., Ltd.20212—
+4K200242StaClear SyringeTribofilm Research, Inc.20205—
+4K190002Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe…Shanghai Kohope Medical Devices Co., Ltd.201913—
+4K170218Vesco Medical NRFit Tip SyringesVesco Medical, LLC20174—
+4K153537Sol-M Insulin Syringe, Sol-M TB SyringeSol-Millennium Medical, Inc.20165—
+4K152808U&U Insulin Syringe with/without Safety Retractable DeviceU&U Medical Technology Co, Ltd.20165—
+4K113673Mysafety SyringeMedicalchain Internartional Corporation20120—
+5K253068Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin SyringeCMT Health PTE., Ltd.20260—
+5K252631Profoject™ Disposable NeedleCMT Health PTE., Ltd.20250—
+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—
+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—
+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—
+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—
+6K242434Insulin SyringesChirana T. Injecta20240—
+6K241856Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…Hlb Lifescience Co., Ltd.20241—
+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—
+6K220061Safety Insulin SyringesBerpu Medical Technology Co., Ltd.20221—
+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—
+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—