Nephros Receives 510(k) Clearance for Its HDF Assist Module for Dialysis

Nephros has received the FDA’s 510(k) clearance for its HDF Assist Module, which provides hemodiafiltration therapy to patients with end-stage renal disease.

HDF is a form of renal replacement therapy that removes more solutes than standard hemodialysis. It is usually used in intensive care settings.

The Nephros module can be used with an existing hemodialysis machine to provide HDF therapy “without the purchase of a new, costly machine,” the company said.

South Orange, N.J.-based Nephros specializes in filtration and pathogen detection products for the medical and commercial markets.