510(k) Report

Devices descending from K024112

37 later devices reach BD 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—
+1K162081BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD…Becton, Dickinson and Company20161—
+1K151870BD U-500 Insulin SyringeBecton, Dickinson and Company20160—
+1K110882Imc Insulin SyringeInternational Medsurg Connection20110—
+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
+1K063348Top Fine Insulin SyringeDaejin Tech Medical Manufacturing Co., Ltd.20071—
+1K062702Ulticare Disposable Syringes and NeedlesUltimed, Inc.200661
+1K040036Inviro Snap Safety Insulin Syringe, 1 CC, Model 102905Inviro Medical200410—
+1K033373Monoject Insulin SyringeTyco Healthcare200301
+2K241385Omnifix Syringe NRFitB.Braun Medical, Inc.20240—
+2K222852Nipro SafeTouch Needle; Nipro Syringe with SafeTouch NeedleNipro Medical Corporation20230—
+2K193101Omnifix Low Dead Space Luer Lock SyringeB.Braun Medical, Inc.20200—
+2K190054BD Insulin SyringeBecton, Dickinson and Company201928
+2K152879Sure-Fine Insulin SyringesShina Med Corporation20163—
+2K120127Swan Valley Medical Tranurethral Suprapubic Endo-Cystostomy (T-Spec) Surgical SystemSwan Valley Medical, Incorporated20120—
+2K092413Invirosnap 50 and 100 Unit Insulin Safety SyringesInviro Medical Devices, Inc.20090—
+2K070917Feel-Ject Insulin SyringeFeel Tech200751
+2K050131Insosafe Bak'snap Retractable Insulin Safety SyringeM.K. Meditech Co., Ltd.20058—
+3K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLC20260—
+3K212499BD Insulin Syringe (0.3mL)Becton, Dickinson and Company20220—
+3K191531Sure-Fine Insulin SyringesShina Med Corporation201921
+3K152803Sungshim Sterile Single Use Insulin SyringeSung Shim Medicare Co., Ltd.20160—
+3K152808U&U Insulin Syringe with/without Safety Retractable DeviceU&U Medical Technology Co, Ltd.20165—
+3K1424363S Safety Insulin SyringeSincere Medical Device Co., Ltd.20150—
+3K122787Comfort EZSimple Diagnostics, Inc.20120—
+3K102178Easy TouchMhc Medical Products20100—
+3K091474Easy.Touch Insulin SyringeMasters Healthcare, LLC20091—
+3K072037Careo Safety Syringe for U-100 Insulin 0.5CC/MLLife-Shield Products, Inc.20070—
+4K210848Sure-Fine Insulin SyringesShina Med Corporation20221—
+4K202570Insulin Syringe, Insulin Syringe with Safety RetractableJiangsu Micsafe Medical Technology Co., Ltd.20212—
+4K191639TK Insulin Syringe with/without Saftey Retractable DeviceAnhui Tiankang Medical Technology Co., Ltd.20200—
+4K193022Retractable Safety Insulin SyringeJiangsu Caina Medical Co.,Ltd20200—
+5K250510Sure-Fine Insulin SyringesShina Med Corporation20250—
+5K220061Safety Insulin SyringesBerpu Medical Technology Co., Ltd.20221—
+6K230061Insulin SyringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.20230—