510(k) Report

Devices descending from K010131

12 later devices reach PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233557HemoCare Hemodialysis SystemDeka Research and Development20240—
+1K2315345008X Hemodialysis SystemFresenius Medical Care202421
+1K112314Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 HemodiafilterNephros, Inc.20125—
+1K081043Leak Detection Sensor and Tray Accessory KitNxstage Medical, Inc.20080—
+1K043436Nxstage Dialysate Preparation Module, Model NX0269Nxstage Medical, Inc.20055—
+2K2435055008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC202516
+2K210575HDF Assist Mudule, HDF Infusion Set and Substitution FilterNephros20221—
+2K060296Nxstage Dialysate Preparation ModuleNxstage Medical, Inc.20063—
+3K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC20250—
+3K080919Nxstage Pureflow SLNxstage Medical, Inc.200821
+4K111174Nxstage Pureflow SLNxstage Medical, Inc.201119
+5K140571Nxstage Pureflow SLNxstage Medical, Inc.201409