510(k) Report

Devices descending from K032004

23 later devices reach Aquaboss Ecoro Dia 50 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140866Tablo ConsoleHome Dialysis Plus201416—
+1K124059Aquaboss Ecoro Dia I (HT); Aquaboss Ecoro Dia II (HT)Lauer Membran Wassertechnik GmbH20135—
+2K223479AQUAbase nXB.Braun Medical, Inc.20230—
+2K193670SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube SetQuanta Dialysis Technologies, Ltd.20203—
+2K150880Tablo Console with Wireless CapabilityOutset Medical201511—
+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—
+3K210661SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood TubesetQuanta Dialysis Technologies, Ltd.20212—
+3K160881Tablo ConsoleOutset Medical, Inc.201610—
+4K252181AquaAFresenius Medical Care North America20250—
+4K242269SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set…Quanta Dialysis Technologies, Ltd.20240—
+4K222067SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube SetQuanta Dialysis Technologies, Ltd.20220—
+4K200741Tablo Hemodialysis SystemOutset Medical, Inc.202071
+4K190793Tablo Hemodialysis System, Tablo CartridgeOutset Medical, Inc.201922
+5K211370Tablo Hemodialysis SystemOutset Medical, Inc.202261
+5K210782Tablo CartridgeOutset Medical, Inc.20211—
+6K233798Moda-flx Hemodialysis System and CartridgeDiality, Inc.20240—
+6K233557HemoCare Hemodialysis SystemDeka Research and Development20240—
+6K223248Tablo® Hemodialysis SystemOutset Medical, Inc.20234—
+7K232776Tablo® Hemodialysis System; TabloCart™ with Prefiltration DrawerOutset Medical, Inc.202401
+7K233335Tablo® Hemodialysis SystemOutset Medical, Inc.20231Class I
+8K253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.20260—