510(k) Report

Devices descending from K093608

13 later devices reach Gambro Water Purification Unit, Models Wro 300 and Wro 300 H through their predicates, nearest generation first.

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