510(k) Report

Devices descending from K982541

25 later devices reach Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223854Unistik® ShieldLock, Unistik VacuFlipOwen Mumford, Ltd.20230—
+1K200932Blood Collection NeedlesVacutest Kima Srl20210—
+1K202325EasyPoint Blood Collection PlusRetractable Technologies, Inc.20210—
+1K181730BD Vacutainer Eclipse UltraFill Blood Collection NeedleBecton, Dickinson and Company20190—
+1K170824BD Vacutainer Eclipse Signal Blood Collection NeedleBecton, Dickinson and Company20180—
+1K172763Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with…Zhejiang Kindly Medical Devices Co., Ltd.201813—
+1K153388IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection…Guangzhou Improve Medical Instruments Co., Ltd.20160—
+1K033478Vacuette Quickshield Safety Tube HolderGreiner Bio-One Vacuette North America20035—
+2K230080Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set…Yangzhou Medline Industry, Co., Ltd.20231—
+2K212019Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single…Jiangsu Micsafe Medical Technology Co., Ltd.20211—
+2K200027Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without…Jiangsu Caina Medical Co.,Ltd20206—
+2K182146Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care…Sol-Millennium Medical, Inc.20181—
+2K102774Vacuette Quickshield with Snappy Tude HolderGreiner Bio-One North America, Inc.201021
+2K072320Greiner Vacuette Quickshield CompleteGreiner Bio-One North America, Inc.200711
+3K250961Blood collection tube holdersPromisemed Hangzhou Meditech Co., Ltd.20250—
+3K233979VACUETTE® QUICKSHIELD Complete (Plus)Greiner Bio-One North America, Inc.20240—
+3K223323Blood Collection Needle (with/without Needle Holder)Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.20230—
+3K222478BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer DeviceBecton, Dickinson and Company20231—
+3K213690Eclipse Blood Collection SetEclipse Medcorp, LLC20220—
+3K222141Safety Blood Collection Needle (Without Needle Holder)Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.20220—
+3K220900Safety Blood Collection Needles with/without Needle HolderAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.20220—
+3K201009CHIRAVAC Blood Collection NeedlesChirana T. Injecta20210—
+3K113505Vacuette Quickshield with Snappy Tube HolderGreiner Bio-One North America, Inc.20121—
+4K252899Female Culture Device; Male Culture Device; Transfer Device; Access DeviceZhejiang Kindly Medical Device Co., Ltd.20260—
+4K173279RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube HolderMyco Medical Supplies, Inc.20180—