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
+1K170386BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes…Becton Dickinson & Company20173—
+1K091167Shina Insulin Syringe-Including Accu-Sure Insulin SyringesShina Corp.20094—
+1K081547Bio-Med Soft Insulin Syringe: Models 1CC, 0.5CC, 0.3CCBio-Med USA, Inc.20080—
+1K071459B. Braun Piston Syringes and Omnican and Omnifix Insulin SyringesB.Braun Medical, Inc.200732
+1K071630Terumo 31G Thinpro Insulin SyringeTerumo Medical Corp.200782—
+1K052561Terumo Micro Tapered Pen NeedleKofu Factory of Terumo Corp.200517—
+1K024112BD Insulin SyringeBecton, Dickinson & CO2003373
+1K021475BD Single Lumen Needle, Syringe and Blood Collection SetBd20021003
+1K992802Terumo U-100 Insulin SyringeTerumo Medical Corp.199984—
+1K991758Monoject Insulin SyringeThe Kendal Co.19993—
+2K240355FROG (Filter Removal of Glass)Carrtech Corp20250—
+2K241385Omnifix Syringe NRFitB.Braun Medical, Inc.20240—
+2K193101Omnifix Low Dead Space Luer Lock SyringeB.Braun Medical, Inc.20200—
+2K190054BD Insulin SyringeBecton, Dickinson and Company201928
+2K163437hypodermic Pinpoint™ GT NeedleC.R. Bard, Inc.20170—
+2K160589Certa Dose PD Epinephrine 1mg/mL IM/SC SyringeCerta Dose, Inc.20170—
+2K162081BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD…Becton, Dickinson and Company20161—
+2K152879Sure-Fine Insulin SyringesShina Med Corporation20163—
+2K151870BD U-500 Insulin SyringeBecton, Dickinson and Company20160—
+2K140516Terumo Pen Injector Needle 34Kofu Factory of Terumo Corp.20144—
+2K133635Easypoint NeedleRetractable Technologies, Inc.201401
+2K120127Swan Valley Medical Tranurethral Suprapubic Endo-Cystostomy (T-Spec) Surgical SystemSwan Valley Medical, Incorporated20120—
+2K110882Imc Insulin SyringeInternational Medsurg Connection20110—
+2K092746Micronjet 600Nanopass Technologies, Ltd.20100—
+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—
+2K072247Sterican Hypodermic NeedlesB.Braun Medical, Inc.20071—
+2K070440BD Hypoint NeedleBecton, Dickinson & CO200791—
+2K063466Top FineDaejin Tech Medical Manufacturing Co., Ltd.200711—
+2K063348Top Fine Insulin SyringeDaejin Tech Medical Manufacturing Co., Ltd.20071—
+2K062702Ulticare Disposable Syringes and NeedlesUltimed, Inc.200661
+2K040036Inviro Snap Safety Insulin Syringe, 1 CC, Model 102905Inviro Medical200410—
+2K033373Monoject Insulin SyringeTyco Healthcare200301
+3K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLC20260—
+3K253047Pressone™Nipro Medical Corporation20260—
+3K250700Pen Injector Needle 32.5Terumo Corporation20250—
+3K222852Nipro SafeTouch Needle; Nipro Syringe with SafeTouch NeedleNipro Medical Corporation20230—
+3K212499BD Insulin Syringe (0.3mL)Becton, Dickinson and Company20220—
+3K210991Disposable Sterile Syringe, Disposable Sterile Syringe with NeedleGuangdong Antmed Co., Ltd.20210—
+3K192082Droplet Pen Needle 34GHtl-Strefa S.A20202—
+3K191531Sure-Fine Insulin SyringesShina Med Corporation201921
+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—
+3K160575CareSens Pen Needle, Softip Pen NeedleYidobio, Inc.20160—
+3K151949Disposable Insulin SyringeJiangyin Caina Technology Co., Ltd.20156—
+3K130230Sterile Piston Hypodermic Syringes (with/Without Needle), Hypodermic NeedlesWuxi Yushou Medical Applicances Co., Ltd.20130—
+3K132552U&U Sterile Hypodermic NeedleU&U Medical Technology Co, Ltd.20136—
+3K124037Jung Rim Single Use Hypodermic Syringe with NeedleJung Rim Medical Industrial Co., Ltd.20130—
+3K131040Extavipro Sterican 30GB.Braun Melsungen AG20130—
+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—
+3K100812Ulticare Disposable Pen NeedlesUltimed, Inc.20109—
+3K092831Disposable Hypodermic NeedleFeel Tech20100—
+3K092413Invirosnap 50 and 100 Unit Insulin Safety SyringesInviro Medical Devices, Inc.20090—
+3K070917Feel-Ject Insulin SyringeFeel Tech200751
+3K050131Insosafe Bak'snap Retractable Insulin Safety SyringeM.K. Meditech Co., Ltd.20058—
+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—
+4K203792Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needlePikdare Spa20230—
+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—
+4K210848Sure-Fine Insulin SyringesShina Med Corporation20221—
+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—
+4K202340Droplet Pen Needle 30G & 33GHtl-Strefa S.A20200—
+4K200242StaClear SyringeTribofilm Research, Inc.20205—
+4K191643TK Sterile Hypodermic NeedleAnhui Tiankang Medical Technology Co., Ltd.20190—
+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—
+4K152803Sungshim Sterile Single Use Insulin SyringeSung Shim Medicare Co., Ltd.20160—
+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—
+4K142765TM Safety NeedleThinkmed Medical Technology Co., Ltd.20154—
+4K1424363S Safety Insulin SyringeSincere Medical Device Co., Ltd.20150—
+4K133100Carefine Pen NeedleFacet Technologies20143—
+4K122787Comfort EZSimple Diagnostics, Inc.20120—
+4K113673Mysafety SyringeMedicalchain Internartional Corporation20120—
+4K113186Sterile Insulin Pen NeedleShina Corp.20124—
+4K102178Easy TouchMhc Medical Products20100—
+4K091474Easy.Touch Insulin SyringeMasters Healthcare, LLC20091—
+4K072037Careo Safety Syringe for U-100 Insulin 0.5CC/MLLife-Shield Products, Inc.20070—
+5K253068Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin SyringeCMT Health PTE., Ltd.20260—
+5K252631Profoject™ Disposable NeedleCMT Health PTE., Ltd.20250—