510(k) Report

Devices descending from K955585

45 later devices reach V2 Injection Site through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083723A6 Luer Access DeviceB.Braun Medical, Inc.20093166
+1K073396Antimicrobial Ultrasite Value, Ultrasite AGB.Braun Medical, Inc.20080—
+1K031923Ultrasite ValveB.Braun Medical, Inc.200332—
+1K024124System 100-UF 500 Circuit with in-Line Needleless Access PortChf Solutions, Inc.20031—
+1K021488Surecan Safety Huber Needle Infusion SetsB.Braun Medical, Inc.20020—
+1K974145V3 ValveB.Braun Medical, Inc.19980—
+1K973167Positive Pressure ConnectorIcu Medical, Inc.199735—
+2K140311Caresite Luer Access DeviceB.Braun Medical, Inc.2014121
+2K100434Clave NeutronIcu Medical, Inc.2010283
+2K021692CLC2000 Catheter Patency DeviceIcu Medical, Inc.200329—
+2K023874System 100 Ultrafiltration CatheterChf Solutions, Inc.20030—
+2K991653Invision-Plus Injection Port Connector SystemRymed Technologies, Inc.1999314
+3K250616Clave™ Neutral-Displacement Needlefree ConnectorsIcu Medical, Inc.20250—
+3K212842Microvolume Luer Access DeviceB.Braun Medical, Inc.20220—
+3K162826Encore NeutralRymed Technologies, LLC20170—
+3K132413MZ1000Care Fusion201326—
+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
+4K203796Firefly Needleless ConnectorPuracath Medical, Inc.20211—
+4K200891BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter SystemBecton, Dickinson and Company20210—
+4K210217Needleless ConnectorJiangsu Caina Medical Co.,Ltd20210—
+4K170336BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless ConnectorBecton, Dickinson and Company20176—
+4K143234MaxZero Administration SetsCare Fusion20140—
+4K140831Maxzero Extension Set with Needless ConnectorCare Fusion201413—
+4K132734Neutral Luer Activated Device (One-Link Needle-Free IV Connector) and Extension SetsBaxter Healthcare Corp201302
+5K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.20260—
+5K222780LILY Extension Tube and Needleless ConnectorLily Medical Corporation20230—
+5K193088MaxZero Extension Sets with Needle-Free Connector (s)Carefusion, Inc.20200—
+5K183399BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc.201953
+5K171118Carefusion NeutraClear multi-fuse Extension Set with needle-free connector (s)Cair Lgl20170—
+5K171957MaxZero Extension Sets with Needless ConnectorCarefusion 303, Inc.2017034
+5K162804Q2 Low Pressure Power Injection Extension SetQuest Medical, Inc.20174—
+5K153293Extension SetB.Braun Medical, Inc.201638
+6K243403BD Nexiva™ Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc.20251—
+6K232234Nouvo Safety SetPoly Medicure Limited20240—
+6K230528Extension SetMedcaptain Life Science Co., Ltd.20230—
+6K231239Nexiva™ Closed IV Catheter System with NearPort™ IV AccessBecton Dickinson Infusion Therapy Systems, Inc.20230—
+6K202618IV Administration SetsB.Braun Medical, Inc.202101
+6K202060Disposable IV catheterShinva Ande Healthcare Apparatus Co., Ltd.20210—
+6K191658IV Sets not made with PVCB.Braun Medical, Inc.202001
+6K182897Velano Vascular Q2 Extension SetVelano Vascular20193—
+7K261041ClearSafe Closed SystemMedSource Labs, LLC20260—
+7K200439Velano ExT Extension SetVelano Vascular20212—
+8K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free…Np Medical20250—
+8K221518NP Medical nCompass Extension Set with Stabilizing BaseNp Medical20220—