510(k) Report

Devices descending from K941657

54 later devices reach BD Micro Fine, Ultra Fine, and Allergy 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—
+1K123588Intradermal AdapterWest Pharmaceutical Services, Inc.20133—
+1K091167Shina Insulin Syringe-Including Accu-Sure Insulin SyringesShina Corp.20094—
+1K052551Devon Standard Syringe, Hypodermic Needle and Insulin SyringeDevon Safety Products, Inc.20050—
+1K021993Shanchuan SyringeShangdong Zibo Shanchuan Medical Instruments Co.20031—
+1K024112BD Insulin SyringeBecton, Dickinson & CO2003373
+1K980796Terumo Allergy SyringeTerumo Corp.19987—
+1K962084Omnican SyringeB. Braun Medical AG19971—
+2K190054BD Insulin SyringeBecton, Dickinson and Company201928
+2K181369Immucise Intradermal Injection SystemTerumo Corporation20181—
+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—
+2K151777Intradermal AdapterWest Pharmaceutical Services, Inc.20150—
+2K110882Imc Insulin SyringeInternational Medsurg Connection20110—
+2K110456Pharmajet 0.1 ML Intradermal Needle-Free Injection SystemPharmajet, Inc.20111—
+2K092746Micronjet 600Nanopass Technologies, Ltd.20100—
+2K081547Bio-Med Soft Insulin Syringe: Models 1CC, 0.5CC, 0.3CCBio-Med USA, Inc.20080—
+2K071459B. Braun Piston Syringes and Omnican and Omnifix Insulin SyringesB.Braun Medical, Inc.200732
+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
+2K024249Terumo Surguard Safety SyringeTerumo Medical Corp.20033—
+2K983994UnifineOwen Mumford USA, Inc.19990—
+3K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLC20260—
+3K241385Omnifix Syringe NRFitB.Braun Medical, Inc.20240—
+3K222852Nipro SafeTouch Needle; Nipro Syringe with SafeTouch NeedleNipro Medical Corporation20230—
+3K212499BD Insulin Syringe (0.3mL)Becton, Dickinson and Company20220—
+3K193101Omnifix Low Dead Space Luer Lock SyringeB.Braun Medical, Inc.20200—
+3K191531Sure-Fine Insulin SyringesShina Med Corporation201921
+3K190427ImmuciseTerumo Corporation20190—
+3K120127Swan Valley Medical Tranurethral Suprapubic Endo-Cystostomy (T-Spec) Surgical SystemSwan Valley Medical, Incorporated20120—
+3K121270Bioject Needle-Free Injection Management SystemBioject Medical Technologies, Inc.20120—
+3K092413Invirosnap 50 and 100 Unit Insulin Safety SyringesInviro Medical Devices, Inc.20090—
+3K072482Hypodermic Needle-Pro Safety Allergy TraySmiths Medical Asd, Inc.20070—
+3K070917Feel-Ject Insulin SyringeFeel Tech200751
+3K063755Portex Hypodermic Needle-Pro Fixed Needle SyringeSmiths Medical Asd, Inc.20072Class I
+3K050131Insosafe Bak'snap Retractable Insulin Safety SyringeM.K. Meditech Co., Ltd.20058—
+4K210848Sure-Fine Insulin SyringesShina Med Corporation20221—
+4K152803Sungshim Sterile Single Use Insulin SyringeSung Shim Medicare Co., Ltd.20160—
+4K152808U&U Insulin Syringe with/without Safety Retractable DeviceU&U Medical Technology Co, Ltd.20165—
+4K1424363S Safety Insulin SyringeSincere Medical Device Co., Ltd.20150—
+4K122787Comfort EZSimple Diagnostics, Inc.20120—
+4K102178Easy TouchMhc Medical Products20100—
+4K093176Med-LokSta-Med, LLC20100—
+4K091474Easy.Touch Insulin SyringeMasters Healthcare, LLC20091—
+4K072037Careo Safety Syringe for U-100 Insulin 0.5CC/MLLife-Shield Products, Inc.20070—
+5K250510Sure-Fine Insulin SyringesShina Med Corporation20250—
+5K202570Insulin Syringe, Insulin Syringe with Safety RetractableJiangsu Micsafe Medical Technology Co., Ltd.20212—
+5K191639TK Insulin Syringe with/without Saftey Retractable DeviceAnhui Tiankang Medical Technology Co., Ltd.20200—
+5K193022Retractable Safety Insulin SyringeJiangsu Caina Medical Co.,Ltd20200—
+6K220061Safety Insulin SyringesBerpu Medical Technology Co., Ltd.20221—
+7K230061Insulin SyringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.20230—