510(k) Report

Devices descending from K951254

114 later devices reach Safetyglide Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082908Novaguard, Model 3611001West Pharmaceutical Services, Inc.20090—
+1K073206Needle-Trap/Needle Safety LabelSchreiner Medipharm20080—
+1K050106Novofine Autocover 30G X 8MMNovo Nordisk, Inc.200534—
+1K041399Hypodermic Needle-Pro Edge Needle Protection DeviceSmiths Medical Asd, Inc.2004114
+1K022117Majestik (TM) Shielded Angiography Needle, Model STAN18T71W-25, Majestik (TM) Shielded…Merit Medical Systems, Inc.20020—
+1K012736Monoject Safety NeedleTyco Healthcare2001293
+1K990803Medisystems Buttonhole Needle SetsMedisystems Corp.200061
+1K972527Phaseal, System for Sealed Handling of Chemotherapeutic AgentsQuality System Consulting199756—
+2K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.20260—
+2K151311Safe Block Pen NeedleArtsana S.P.A201611—
+2K134019Medisystems Onesite Dual Lumen Needle with Masterguard Anti-Stick Needle Protector…Nxstage Medical, Inc.20140—
+2K130873Vwing Vascular Needle Guide, 4MM X 07MM; Vwing Vascular Needle Guide, 6MM X 07MM; Vwing…Vital Access20130—
+2K120384Protector, Injector, ConnectorBd Medical-Medical Surgical Systems201235—
+2K110527K-Pack Surshield Needle, Hypodermic Needle for Single UseTerumo Europe N.V.20113—
+2K093109Novotwist Needle, Models 30G * 8MM (1/3) 32 G Tip * 5 MM (1/5')Novo Nordisk, Inc.20104—
+2K090111Flexpen NeedleNovo Nordisk, Inc.201016—
+2K092782Injector Luer, Model N34, Injector Luer Lock, Model N35, Injector Luer Lock, N35C…Carmel Pharma Ab.200936—
+2K083152Equashield SystemPlastmed, Ltd.20099—
+2K082882A.V. Fistula Blunt Needle SetJms North America Corp.20092—
+2K071785Hypodermic Needle-Pro Edge Safety Device, Hypodermic Needle-Pro Edge Safety Device with…Smiths Medical Asd, Inc.20077—
+2K063368Nipro Biohole NeedleNipro Medical Corp.20070—
+2K063450Portex Hypodermic Needle- Pro Edge Safety Device, 18GX1, 401810, 19GX1, 401910…Smiths Medical Asd, Inc.20078—
+2K062500Flexpen NeedleNovo Nordisk, Inc.200617—
+2K061194Portex Needle-Pro Edge Safety with Syringe, Models 432310, 432210, 432510, 432558Smiths Medical Asd, Inc.20069—
+2K053049Alaris Safety Male LuerCardinal Health, Alaris Products2006143
+2K980381Phaseal, Closed System Forhandling of Parenteral Drugs, Additional Administration…Carmel Pharma Ab.199849—
+3K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.20260—
+3K223076BD Texium™ Closed Male LuerCare Fusion20231—
+3K211634Hypodermic Needle-Pro EDGE Safety DeviceSmiths Medical Asd, Inc.20215—
+3K173479NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)Novo Nordisk, Inc.20181—
+3K161950Common Type Insulin Pen Needle, Safety Type Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20179—
+3K133738Novofine Plus 32G 4 MMNovo Nordisk, Inc.20142—
+3K132011Apoteca Dug Compounding Dosing Device,Apoteca I.V. Transfer SetAea Srl20140—
+3K133100Carefine Pen NeedleFacet Technologies20143—
+3K123213BD Phaseal Closed System Transfer DeviceBecton, Dickinson & CO2013342
+3K121554Q-Flo Closed Male Luer ConnectorUs Fusion, LLC. Dba Truecare Biomedix-USA20120—
+3K120191Push-on Needle 30GX8MMScandinavian Health Limited20120—
+3K113186Sterile Insulin Pen NeedleShina Corp.20124—
+3K11179727 G X 1/2 K-Pack Surshield NeedleTerumo Europe N.V.20112—
+3K101940Equashield System Protective PlusEquashield Medical, Ltd.20107—
+3K093637JMS Blunt a. V. Fistula Needle Set with Site Preparation Tool Model 820-5300, 820-6300…Jms North America Corp.20101—
+3K091389Equalshield Luer Lock Connector PairPlastmed, Ltd.20098—
+3K073188Hypodermic Needle-Pro Edge Safety DeviceSmiths Medical Asd, Inc.20080—
+3K072759VIAL2BAGMedimop Medical Projects, Ltd.20072Class I
+3K071741Tevadaptor, Closed Drug Reconstitution and Transfer SystemMigada Plant2007111
+3K071108Texium SyringeCardinal Health, Alaris Products2007111
+3K060866Phaseal - Closed System for the Preparation and Administration of Parenteral DrugsCarmel Pharma Ab.200636—
+3K051669Tevadaptor Closed Drug Reconstitution and Transfer SystemMigada Plant2005131
+3K023747PhasealCarmel Pharma Ab.200238—
+4K24330927G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)Terumo Europe N.V.20250—
+4K242632Verifine® Pen NeedlesPromisemed Hangzhou Meditech Co., Ltd.20240—
+4K232943Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space SyringeSmiths Medical Asd, Inc.20244—
+4K222929ToxiSeal Vial Adapter with External BalloonEpic Medical Pte., Ltd.20242—
+4K231888BD Texium™ Needle-Free SyringeCare Fusion20230—
+4K223353DropSafeTM SicuraTMPikdare Spa20220—
+4K210748Well-life TM Pen Needles, Well-life TM Safety Pen NeedlesW. L. Med Co., Ltd.20221—
+4K210059Promisemed Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20211—
+4K210258NovoFineNovo Nordisk, Inc.20210—
+4K210065Verifine Safety Type Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20210—
+4K193422Easydrip Pen Needle, Easydrip Plus Pen NeedleSandstone Medical (Suzhou), Inc.20211—
+4K202681Promisemed Covered Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20200—
+4K202005NovoFine Plus 32G Tip x 4 mmNovo Nordisk, Inc.20201—
+4K192075ProSeal™ Closed System drug Transfer Device (CSTD)Epic Medical Pte., Ltd.20204—
+4K191853Dual-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20191—
+4K181221BD PhaSeal Optima Closed System Transfer DeviceBecton, Dickinson and Company201821
+4K172499NeoshieldJMS North America Corporation20180—
+4K152877SureFine Pen NeedleShina Med Corporation20161—
+4K150486HaloJ & J Solutions, Inc. D/B/A/ Corvida Medical201511
+4K151017JMS Harmony A.V. Fistula Needle SetJMS North America Corporation20150—
+4K141448Tevadaptor Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant20159—
+4K141749Carefine Pen Needle Family Including Quintapoint and SuperpointFacet Technologies, LLC20140—
+4K140730VIAL2BAG Direct ConnectMedimop Medical Projects, Ltd.201411
+4K140591BD Phaseal Closed System Transfer Device - InjectorBecton, Dickinson & CO201421
+4K132899Equashield Closed System Drug Transfer Device (CSTD)Equashield Medical, Ltd.20146—
+4K140568Carefine Pen Needle with Quintapoint and SuperpointFacet Technologies, LLC20141—
+4K131549Chemolock, Chemolock PortIcu Medical, Inc.201310Class I
+4K130197BD Phaseal Closed System Transfer Device - P55Becton, Dickinson and Company2013191
+4K110023Infusion Adapter C100Carmel Pharma Ab.201137—
+5K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead…CMT Health PTE., Ltd.20260—
+5K260855Profoject™ Safety Pen NeedlesCMT Health PTE., Ltd.20260—
+5K252908Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle…Sandstone Medical (Suzhou), Inc.20260—
+5K250059BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O)Becton, Dickinson and Company20250—
+5K250658SureFine Pen NeedleShina Med Corporation20250—
+5K242291SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead…Sol-Millennium Medical, Inc.20242—
+5K241476ToxiSeal™ Vial Adaptor with External Flip BalloonEpic Medical Pte., Ltd.20241—
+5K240171ProSeal™ Injector Plus (Model no. 421050)Epic Medical Pte., Ltd.20243—
+5K231255NovoFine® PlusNovo Nordisk, Inc.20230—
+5K222739Disposable Insulin Pen NeedleHantech Medical Device Co., Ltd.20230—
+5K201422Arisure Closed System Drug Transfer Device (CSTD)Yukon Medical, LLC20211—
+5K202682Promisemed Triple Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20200—
+5K201099BD PhaSeal Optima Closed System Drug Transfer DeviceBecton, Dickinson and Company202001
+5K192866Chemfort CSTDSimplivia Healthcare, Ltd.202031
+5K180489TEVADAPTOR Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant20181—
+5K180574Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo…J & J Solutions, Inc. D/B/A/ Corvida Medical20180—
+5K172631Arisure Dry SpikeYukon Medical20170—
+5K171144Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 BevelMedbio, LLC20170—
+5K170706Equashield Closed System drug Transfer Device (CSTD)Equashield Medical, Ltd.20175—
+5K170680TEVADAPTOR Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant20170—
+5K170095Vial2Bag Direct ConnectMedimop Medical Project, Ltd.20170Class I
+6K252814Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead…CMT Health PTE., Ltd.20260—