510(k) Report

Devices descending from K042797

14 later devices reach Wro 300 Water Purification System for Hemodialysis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093608Gambro Water Purification Unit, Models Wro 300 and Wro 300 HGambro Renal Products, Inc.201013—
+2K200670EON Portable RO Water Purification SystemMar Cor Purification, Inc.20200—
+2K192398Millenium HXMar Cor Purification, Inc.20190—
+2K143617AquaC UNO HVivonic GmbH201515
+2K124059Aquaboss Ecoro Dia I (HT); Aquaboss Ecoro Dia II (HT)Lauer Membran Wassertechnik GmbH20135—
+2K110578Millenium HX Portable Reverse Osmosis Water Purification SystemMar Cor Purification, Inc.201161
+3K250471AquaC UNO HFresenius Medical Care Renal Therapies Group, LLC20250—
+3K223479AQUAbase nXB.Braun Medical, Inc.20230—
+3K171099EON Portable Reverse Osmosis Water Purification SystemCantel20181—
+3K133149Biopure HX2 Reverse Osmosis Water Purification SystemMar Cor Purification, Inc.20140—
+3K133829Aquabplus,Aquabplus & Aquabplus B2,Aquabplus&Aquabplus HF,Aquabplus& Aquabplus B2&…Vivonic GmbH201433
+4K232953AquaBplus; AquaB LITEFresenius Medical Care Renal Therapies Group, LLC20240—
+4K213507AquaAFresenius Medical Care Rental Therapies Group, LLC20221—
+5K252181AquaAFresenius Medical Care North America20250—