510(k) Report

Devices descending from K970855

82 later devices reach Clave Connector through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220267AMSafe NeuFlo Needleless ConnectorAmsino International, Inc.20220—
+1K213004Needle Free ConnectorMedcaptain Life Science Co., Ltd.20220—
+1K121511Maclin Power Intravascular Administration SetMaclin Power, Inc.20130—
+1K120799Arisure Neutral ValveYukon Medical, LLC20122—
+1K100434Clave NeutronIcu Medical, Inc.2010283
+1K093271Extension Set (Standardbore Tubing), Extension Set (Minibore Tubing), IV Administration…Victus, Inc.20100—
+1K090189Antimicrobial Clave, Models AG Clave, AG MicroclaveIcu Medical, Inc.20090—
+1K081361Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXXIcu Medical, Inc.200812Class I
+1K080007Graduated Adapter with ClaveIcu Medical, Inc.20080—
+1K080077Clave StopcockIcu Medical, Inc.200804
+1K051437CML 1000Icu Medical, Inc.200516—
+1K030246Victus I.V. Administration Set, Models 27071 and 27072Victus, Inc.20031—
+1K013621BD Saf-T PRN Luer Activated Valve, Model 385100Becton Dickinson Infusion Therapy Systems, Inc.2002211
+1K984060Luer Access Injection SiteBaxter Healthcare Corp19991—
+1K973167Positive Pressure ConnectorIcu Medical, Inc.199735—
+2K250616Clave™ Neutral-Displacement Needlefree ConnectorsIcu Medical, Inc.20250—
+2K173477ChemoCLAVE Cytotoxic Medication Preparation and Delivery SystemIcu Medical, Inc.201809
+2K142527Extension Set with BD Q-Syte Luer Access Split SeptumAcacia, Inc.20141—
+2K133073Cair Drive, NeutraclearCair Lgl20141—
+2K132413MZ1000Care Fusion201326—
+2K131549Chemolock, Chemolock PortIcu Medical, Inc.201310Class I
+2K112636Cytoguard (TM) Closed Luer ConnectorB.Braun Medical, Inc.201101
+2K053049Alaris Safety Male LuerCardinal Health, Alaris Products2006143
+2K042936Solution Administration with Luer Access Injection SiteBaxter Healthcare Corp200401
+2K021692CLC2000 Catheter Patency DeviceIcu Medical, Inc.200329—
+2K991653Invision-Plus Injection Port Connector SystemRymed Technologies, Inc.1999314
+3K223076BD Texium™ Closed Male LuerCare Fusion20231—
+3K203796Firefly Needleless ConnectorPuracath Medical, Inc.20211—
+3K200891BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter SystemBecton, Dickinson and Company20210—
+3K210217Needleless ConnectorJiangsu Caina Medical Co.,Ltd20210—
+3K202672Precision Delivery Infusion SetQuest Medical, Inc.202101
+3K171117Carefusion NeutraClear Needle-free connector (EL-NC1000)Cair Lgl20170—
+3K162826Encore NeutralRymed Technologies, LLC20170—
+3K170336BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless ConnectorBecton, Dickinson and Company20176—
+3K141448Tevadaptor Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant20159—
+3K143234MaxZero Administration SetsCare Fusion20140—
+3K140831Maxzero Extension Set with Needless ConnectorCare Fusion201413—
+3K121554Q-Flo Closed Male Luer ConnectorUs Fusion, LLC. Dba Truecare Biomedix-USA20120—
+3K120443Neutral Luer Activated Device and Extension Sets with Neutral Luer Activated DeviceBaxter Healthcare Corporation - Renal Division201228—
+3K093489IN Vision-Plus Nano with Neutral Advantage TechnologyRymed Technologies, Inc.201001
+3K071108Texium SyringeCardinal Health, Alaris Products2007111
+4K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.20260—
+4K222780LILY Extension Tube and Needleless ConnectorLily Medical Corporation20230—
+4K231888BD Texium™ Needle-Free SyringeCare Fusion20230—
+4K201422Arisure Closed System Drug Transfer Device (CSTD)Yukon Medical, LLC20211—
+4K193088MaxZero Extension Sets with Needle-Free Connector (s)Carefusion, Inc.20200—
+4K192866Chemfort CSTDSimplivia Healthcare, Ltd.202031
+4K183399BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc.201953
+4K180489TEVADAPTOR Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant20181—
+4K171118Carefusion NeutraClear multi-fuse Extension Set with needle-free connector (s)Cair Lgl20170—
+4K171957MaxZero Extension Sets with Needless ConnectorCarefusion 303, Inc.2017034
+4K170680TEVADAPTOR Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant20170—
+4K162804Q2 Low Pressure Power Injection Extension SetQuest Medical, Inc.20174—
+4K153293Extension SetB.Braun Medical, Inc.201638
+4K132734Neutral Luer Activated Device (One-Link Needle-Free IV Connector) and Extension SetsBaxter Healthcare Corp201302
+4K083152Equashield SystemPlastmed, Ltd.20099—
+5K253033Chemfort® 28-day 20 mm Vial Adaptor and 13 mm ConvertorSimplivia Healthcare, Ltd.20250—
+5K251411Chemfort Female Luer Lock AdaptorSimplivia Healthcare, Ltd.20250—
+5K243403BD Nexiva™ Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc.20251—
+5K240517ProSeal™ Vented Universal Vial AdaptorEpic Medical Pte., Ltd.20240—
+5K232234Nouvo Safety SetPoly Medicure Limited20240—
+5K230528Extension SetMedcaptain Life Science Co., Ltd.20230—
+5K231239Nexiva™ Closed IV Catheter System with NearPort™ IV AccessBecton Dickinson Infusion Therapy Systems, Inc.20230—
+5K231286Chemfort® Catheter AdaptorSimplivia Healthcare, Ltd.20230—
+5K202618IV Administration SetsB.Braun Medical, Inc.202101
+5K210707OnGuard2 Chemfort Closed Administration (CADM)Simplivia Healthcare, Ltd.20210—
+5K202060Disposable IV catheterShinva Ande Healthcare Apparatus Co., Ltd.20210—
+5K191658IV Sets not made with PVCB.Braun Medical, Inc.202001
+5K182897Velano Vascular Q2 Extension SetVelano Vascular20193—
+5K101940Equashield System Protective PlusEquashield Medical, Ltd.20107—
+5K091389Equalshield Luer Lock Connector PairPlastmed, Ltd.20098—
+6K261041ClearSafe Closed SystemMedSource Labs, LLC20260—
+6K200439Velano ExT Extension SetVelano Vascular20212—
+6K132899Equashield Closed System Drug Transfer Device (CSTD)Equashield Medical, Ltd.20146—
+7K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free…Np Medical20250—
+7K221518NP Medical nCompass Extension Set with Stabilizing BaseNp Medical20220—
+7K170706Equashield Closed System drug Transfer Device (CSTD)Equashield Medical, Ltd.20175—
+8K221513Equashield Closed System Transfer DeviceEquashield Medical, Ltd.20230—
+8K201460Closed System Transfer DeviceShinva Ande Healthcare Apparatus Co., Ltd.20223—
+9K241988ProSeal™ Closed System Bag AccessEpic Medical Pte., Ltd.20242—
+10K251340ProSeal™ Bag Spike with Additive Port (423370ST, 423370)Epic Medical Pte., Ltd.20250—
+10K243976ZeroClear™ Bag Access (423100)Epic Medical Pte., Ltd.20250—