510(k) Report

Devices descending from K083472

32 later devices reach Medegen Pressure Rated Extension Sets through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153293Extension SetB.Braun Medical, Inc.201638
+1K140831Maxzero Extension Set with Needless ConnectorCare Fusion201413—
+1K120443Neutral Luer Activated Device and Extension Sets with Neutral Luer Activated DeviceBaxter Healthcare Corporation - Renal Division201228—
+1K090809MPS Acacia Power Injectable Infusion SetMps Acacia20092—
+2K230528Extension SetMedcaptain Life Science Co., Ltd.20230—
+2K222780LILY Extension Tube and Needleless ConnectorLily Medical Corporation20230—
+2K202618IV Administration SetsB.Braun Medical, Inc.202101
+2K193088MaxZero Extension Sets with Needle-Free Connector (s)Carefusion, Inc.20200—
+2K191658IV Sets not made with PVCB.Braun Medical, Inc.202001
+2K171118Carefusion NeutraClear multi-fuse Extension Set with needle-free connector (s)Cair Lgl20170—
+2K171957MaxZero Extension Sets with Needless ConnectorCarefusion 303, Inc.2017034
+2K162804Q2 Low Pressure Power Injection Extension SetQuest Medical, Inc.20174—
+2K142527Extension Set with BD Q-Syte Luer Access Split SeptumAcacia, Inc.20141—
+2K132734Neutral Luer Activated Device (One-Link Needle-Free IV Connector) and Extension SetsBaxter Healthcare Corp201302
+2K132413MZ1000Care Fusion201326—
+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
+3K182897Velano Vascular Q2 Extension SetVelano Vascular20193—
+3K170336BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless ConnectorBecton, Dickinson and Company20176—
+3K143234MaxZero Administration SetsCare Fusion20140—
+4K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.20260—
+4K200439Velano ExT Extension SetVelano Vascular20212—
+4K183399BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc.201953
+5K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free…Np Medical20250—
+5K243403BD Nexiva™ Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc.20251—
+5K232234Nouvo Safety SetPoly Medicure Limited20240—
+5K231239Nexiva™ Closed IV Catheter System with NearPort™ IV AccessBecton Dickinson Infusion Therapy Systems, Inc.20230—
+5K221518NP Medical nCompass Extension Set with Stabilizing BaseNp Medical20220—
+5K202060Disposable IV catheterShinva Ande Healthcare Apparatus Co., Ltd.20210—
+6K261041ClearSafe Closed SystemMedSource Labs, LLC20260—