510(k) Report

Devices descending from K112314

5 later devices reach Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 Hemodiafilter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K2315345008X Hemodialysis SystemFresenius Medical Care202421
+1K210575HDF Assist Mudule, HDF Infusion Set and Substitution FilterNephros20221—
+2K2435055008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC202516
+2K233557HemoCare Hemodialysis SystemDeka Research and Development20240—
+3K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC20250—