Nephros files 510(k) application with FDA for hemodiafiltration system

Nephros has filed a 510(k) application with the US Food and Drug Administration (FDA) to clear its hemodiafiltration (HDF) system for end-stage renal disease (ESRD).

The HDF system removes harmful substances known collectively as ‘middle molecules’ which tend to cause dialysis-related amyloidosis, carpal tunnel syndrome and degenerative bone disease.

The application details Nephros’s OLpur MD220 diafilter and OLpur H2H Hemodiafiltration module.

Nephros’s OLpur MD220 is a dialyzer designed for HDF therapy which uses its proprietary Mid-Dilution diafiltration technology.

Nephros’s OLpur H2H hemodiafiltration module is designed to enable the standard dialysis machines to perform HDF therapy.