510(k) Report

Devices descending from K010188

14 later devices reach BD Eclipse Hypodermic Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161170BD Eclipse Hypodermic NeedleBecton, Dickinson and Company201631
+1K130097Medmate Transfer Adapter AM5500 & AM5500-NSAmerican Medical Manufacturing, Inc./ Advanced Med20140—
+1K123684Sol-Care Safety NeedleSol-Millennium Medical201322
+1K121283BD Emerald Saf-T Single Use, HypodermicBecton, Dickinson and Company20120—
+1K100209BD Eclipse Needle with Smartslip TechnologyBecton, Dickinson & CO20101—
+1K073206Needle-Trap/Needle Safety LabelSchreiner Medipharm20080—
+1K043397Modification to BD Eclipse Hypodermic NeedleBecton, Dickinson & CO20044—
+2K222271Verisafe Safety sterile needlesPromisemed Hangzhou Meditech Co., Ltd.20230—
+2K214004CCBIO ASCPO NeedleCc Biotechnology Corporation20220—
+2K213054Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety SyringeMedline Industries, Inc.20220—
+2K162081BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD…Becton, Dickinson and Company20161—
+2K152183EXELINT SecureTouch Safety Hypodermic NeedleExelint International, Co.20150—
+2K082908Novaguard, Model 3611001West Pharmaceutical Services, Inc.20090—
+3K222852Nipro SafeTouch Needle; Nipro Syringe with SafeTouch NeedleNipro Medical Corporation20230—