510(k) Report

Devices descending from K003348

27 later devices reach E.N.S.I. Retractable Safety Syringe through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032247U.S. Technologies, Inc. Retractable Safety SyringeU.S. Technologies, Inc.20030—
+1K022806Duopro Safety Syringe (Duopross)M.K. Meditech Co., Ltd.200224—
+1K020623Duopro Safety Syringe (Duopross)M.K. Meditech Co., Ltd.200225—
+2K132557Ewnl Safety Syringe with NeedleJiamei-Un Co., Ltd.20140—
+2K120641Global Medi Products Retractable Safety SyringeGlobal Medi Products20120—
+2K042500Duopross SyringesDuopross Meditech Corporation20054—
+2K032747Biotop DJT-a Safety SyringeBiotop Technology Co., Ltd.20044—
+2K03403110 ML Bak'snap Duopross Retractable Safety SyringeM.K. Meditech Co., Ltd.20046—
+2K031594Bak'snap Duopro Safety Syring (Duopross) Safety'tray Allergy Safety Syringe TrayM.K. Meditech Co., Ltd.200315—
+3K191490Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety…Jiangsu Caina Medical Co.,Ltd20190—
+3K060772Manuel Saftey Syringe Parts 1 & 2Medsafe Asa20060—
+3K060211Wuzhou Syringe, with/Without NeedleWenzhou Wuzhou Group Co., Ltd.20063—
+3K050131Insosafe Bak'snap Retractable Insulin Safety SyringeM.K. Meditech Co., Ltd.20058—
+3K041970Biotop Hooksafe Safety Syringe, Models 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML and 10CC/MLBiotop Technology Co., Ltd.20042—
+4K222925Hypodermic Syringes & NeedleLifelong Meditech Private Limited20230—
+4K222124Sterile Hypodermic Syringe with/without Needle, Hypodermic NeedleAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.20220—
+4K210103Safeway, Lifelong Premium, Lifelong MatrixLifelong Meditech Private Limited20210—
+4K152808U&U Insulin Syringe with/without Safety Retractable DeviceU&U Medical Technology Co, Ltd.20165—
+4K1424363S Safety Insulin SyringeSincere Medical Device Co., Ltd.20150—
+4K072037Careo Safety Syringe for U-100 Insulin 0.5CC/MLLife-Shield Products, Inc.20070—
+4K062318Biotop Hooksafe U-100 Insulin Syringe, Models 0.5CC/ML and 1CC/MLBiotop Technology Co., Ltd.20070—
+4K043038Biotop Hooksafe Luer-Lock Safety Syringe, Models 3CC/ML, 5CC/ML and 10CC/MLBiotop Technology Co., Ltd.20040—
+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—