510(k) Report

Devices descending from K050603

6 later devices reach Olpur Dialyzer, Model HD 190 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112314Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 HemodiafilterNephros, Inc.20125—
+2K2315345008X Hemodialysis SystemFresenius Medical Care202421
+2K210575HDF Assist Mudule, HDF Infusion Set and Substitution FilterNephros20221—
+3K2435055008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC202516
+3K233557HemoCare Hemodialysis SystemDeka Research and Development20240—
+4K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC20250—