510(k) Report

Devices descending from K811678

28 later devices reach Gambro Water Purification Monitor WRD through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042797Wro 300 Water Purification System for HemodialysisGambro Renal Products200514—
+1K010131PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment Kit-1W605,PHD Hard…Aksys, Ltd.2002121
+2K233557HemoCare Hemodialysis SystemDeka Research and Development20240—
+2K2315345008X Hemodialysis SystemFresenius Medical Care202421
+2K112314Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 HemodiafilterNephros, Inc.20125—
+2K093608Gambro Water Purification Unit, Models Wro 300 and Wro 300 HGambro Renal Products, Inc.201013—
+2K081043Leak Detection Sensor and Tray Accessory KitNxstage Medical, Inc.20080—
+2K043436Nxstage Dialysate Preparation Module, Model NX0269Nxstage Medical, Inc.20055—
+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—
+3K192398Millenium HXMar Cor Purification, Inc.20190—
+3K143617AquaC UNO HVivonic GmbH201515
+3K124059Aquaboss Ecoro Dia I (HT); Aquaboss Ecoro Dia II (HT)Lauer Membran Wassertechnik GmbH20135—
+3K110578Millenium HX Portable Reverse Osmosis Water Purification SystemMar Cor Purification, Inc.201161
+3K060296Nxstage Dialysate Preparation ModuleNxstage Medical, Inc.20063—
+4K250471AquaC UNO HFresenius Medical Care Renal Therapies Group, LLC20250—
+4K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC20250—
+4K223479AQUAbase nXB.Braun Medical, Inc.20230—
+4K171099EON Portable Reverse Osmosis Water Purification SystemCantel20181—
+4K133149Biopure HX2 Reverse Osmosis Water Purification SystemMar Cor Purification, Inc.20140—
+4K133829Aquabplus,Aquabplus & Aquabplus B2,Aquabplus&Aquabplus HF,Aquabplus& Aquabplus B2&…Vivonic GmbH201433
+4K080919Nxstage Pureflow SLNxstage Medical, Inc.200821
+5K232953AquaBplus; AquaB LITEFresenius Medical Care Renal Therapies Group, LLC20240—
+5K213507AquaAFresenius Medical Care Rental Therapies Group, LLC20221—
+5K111174Nxstage Pureflow SLNxstage Medical, Inc.201119
+6K252181AquaAFresenius Medical Care North America20250—
+6K140571Nxstage Pureflow SLNxstage Medical, Inc.201409