510(k) Report

Devices descending from K964539

29 later devices reach Portable Series Reverse Osmosis Systems 700, 701, 702, 703, 704, 750, Mre-NF… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110578Millenium HX Portable Reverse Osmosis Water Purification SystemMar Cor Purification, Inc.201161
+1K030348Biopure Portable RO System,Biopure 4400 Series RO System, Biopure 8400 Series RO…Biolab Equipment Canada, Ltd.20032—
+1K021560Modification to Ameriwater Purification System for HemodialysisAmeriwater20030—
+1K010131PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment Kit-1W605,PHD Hard…Aksys, Ltd.2002121
+1K993877Nelson Water Systems for HemodialysisNelson Environmental Technologies, Inc.20000—
+1K993272Pure Water, Inc.'S Bicarb Mix, Storage and Distribution SystemPure Water, Inc.200011
+1K993058Pure Water Inc's Acidified Storage and Distribution System with Optional Remote FillPure Water, Inc.20001—
+1K992786Pure Water, Inc.'S Water Purification SystemsPure Water, Inc.20000—
+2K233557HemoCare Hemodialysis SystemDeka Research and Development20240—
+2K2315345008X Hemodialysis SystemFresenius Medical Care202421
+2K192398Millenium HXMar Cor Purification, Inc.20190—
+2K171099EON Portable Reverse Osmosis Water Purification SystemCantel20181—
+2K143617AquaC UNO HVivonic GmbH201515
+2K133149Biopure HX2 Reverse Osmosis Water Purification SystemMar Cor Purification, Inc.20140—
+2K112331Biopure Portable RO SystemsArion Water, Inc.20120—
+2K112314Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 HemodiafilterNephros, Inc.20125—
+2K120005ACDSIsopure, Corp.201202
+2K112427Bicarb Mixing and Distribution SystemIsopure, Corp.201202
+2K081043Leak Detection Sensor and Tray Accessory KitNxstage Medical, Inc.20080—
+2K043436Nxstage Dialysate Preparation Module, Model NX0269Nxstage Medical, Inc.20055—
+3K250471AquaC UNO HFresenius Medical Care Renal Therapies Group, LLC20250—
+3K2435055008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC202516
+3K210575HDF Assist Mudule, HDF Infusion Set and Substitution FilterNephros20221—
+3K200670EON Portable RO Water Purification SystemMar Cor Purification, Inc.20200—
+3K060296Nxstage Dialysate Preparation ModuleNxstage Medical, Inc.20063—
+4K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC20250—
+4K080919Nxstage Pureflow SLNxstage Medical, Inc.200821
+5K111174Nxstage Pureflow SLNxstage Medical, Inc.201119
+6K140571Nxstage Pureflow SLNxstage Medical, Inc.201409