510(k) Report

Devices descending from K890824

17 later devices reach Fresenius 2008 Touch Panel Control Dialysis System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071013RedsenseRedsense Medical AB20073—
+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
+2K130554Redsense Alarm SystemRedsense Medical AB20130—
+2K112314Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 HemodiafilterNephros, Inc.20125—
+2K103242Redsense-Alarm Unit and SensorRedsense Medical AB20111—
+2K092955Redsense-Home UseRedsense Medical AB20102—
+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—
+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