510(k) Report

Devices descending from K003225

50 later devices reach Solution Administration Sets with Capless Luer Activated Valve through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120443Neutral Luer Activated Device and Extension Sets with Neutral Luer Activated DeviceBaxter Healthcare Corporation - Renal Division201228—
+1K112893Clearlink Luer Activated Valve, Clearlink System Non-Dehp Catheter Extension SetsBaxter Healthcare Corporation201111Class I
+1K103551Interlink S / Clearlink System / V-Link Lad with Vitalshield Protective Coating Non-Dehp…Baxter Healthcare Corp201101
+1K072576Clearlink Antimicrobial Luer Activated Device (Lad) and Extension Sets with the…Baxter Healthcare Corp20074—
+1K040385Multiport Manifold Set with Swabable Valves, Model 9900Quest Medical, Inc.20043—
+2K212262PCA Syringe SetsBaxter Healthcare Corporation20220—
+2K203609Intravascular Administration SetsBaxter Healthcare Corporation202145
+2K192366Intravascular Extension Sets and AccessoriesBaxter Healthcare Corporation20202—
+2K180739Clearlink System Solution SetBaxter Healthcare Corporation201906
+2K162304Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV…Quest Medical, Inc.20160—
+2K151079Q2 Intravenous Adminstration Sets and Extension SetsQuest Medical, Inc.201511
+2K141200Padi-LockPadi-Lock, LLC20140—
+2K132734Neutral Luer Activated Device (One-Link Needle-Free IV Connector) and Extension SetsBaxter Healthcare Corp201302
+2K132413MZ1000Care Fusion201326—
+2K090189Antimicrobial Clave, Models AG Clave, AG MicroclaveIcu Medical, Inc.20090—
+2K081289V-Link Antimicrobial Luer Activated Device and Extension Sets with V-Link Antimicrobial…Baxter Healthcare Corp20083—
+2K051943Sureflow Safety Infusion DeviceIntrasafe Medical, LLC20050—
+3K243529Solution Administration SetsBaxter Healthcare Corporation20250Class I
+3K242339Intravascular Extension Sets and AccessoriesBaxter Healthcare Corporation20250—
+3K221121Volumat Polyethylene I.V. Administration SetFresenius Kabi20230—
+3K220301Volumat LineFresenius Kabi20230—
+3K220312Polyfusion IV Administration SetsPoly Medicure Limited20230—
+3K203796Firefly Needleless ConnectorPuracath Medical, Inc.20211—
+3K210430Intravascular Extension SetBaxter Healthcare Corporation20210—
+3K200891BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter SystemBecton, Dickinson and Company20210—
+3K210217Needleless ConnectorJiangsu Caina Medical Co.,Ltd20210—
+3K170336BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless ConnectorBecton, Dickinson and Company20176—
+3K143234MaxZero Administration SetsCare Fusion20140—
+3K140831Maxzero Extension Set with Needless ConnectorCare Fusion201413—
+3K093489IN Vision-Plus Nano with Neutral Advantage TechnologyRymed Technologies, Inc.201001
+4K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.20260—
+4K222780LILY Extension Tube and Needleless ConnectorLily Medical Corporation20230—
+4K193088MaxZero Extension Sets with Needle-Free Connector (s)Carefusion, Inc.20200—
+4K183399BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc.201953
+4K171118Carefusion NeutraClear multi-fuse Extension Set with needle-free connector (s)Cair Lgl20170—
+4K171957MaxZero Extension Sets with Needless ConnectorCarefusion 303, Inc.2017034
+4K162804Q2 Low Pressure Power Injection Extension SetQuest Medical, Inc.20174—
+4K153293Extension SetB.Braun Medical, Inc.201638
+5K243403BD Nexiva™ Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc.20251—
+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—
+5K202618IV Administration SetsB.Braun Medical, Inc.202101
+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—
+6K261041ClearSafe Closed SystemMedSource Labs, LLC20260—
+6K200439Velano ExT Extension SetVelano Vascular20212—
+7K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free…Np Medical20250—
+7K221518NP Medical nCompass Extension Set with Stabilizing BaseNp Medical20220—