Nephros (OTC:NEPH) said today it won FDA 510(k) clearance for its EndoPur 10″ endotoxin filter designed for dialysis systems.
The River Edge, N.J.-based company said the newly cleared EndoPur 10″ filter is designed to produce hemodialysis quality water for dialysis systems, and fits into existing filter cartridge housings.
Nephros touted the device as having the smallest pore size of any endotoxin barriers on the market.
“With the FDA clearance of the EndoPur, we have achieved a significant milestone in the expansion of our dialysis water filter portfolio We now can provide our industry-leading 5 nanometer pore-size endotoxin protection to all dialysis clinic RO systems, both large clinic-based and small portable. We expect to begin selling the EndoPur to customers in the second quarter of 2017,” prez & CEO Daron Evans said in a prepared statement.
Last December, Nephros said it won FDA 510(k) clearance for its HydraGuard 10″ UltraFilter designed for water bacterial filtration.
The company said its HydraGuard 10″ UltraFilter is designed to provide 6 months of bacterial protection and filtration for potable water sources such as endoscope re-processors, surgical humidifiers and ice machines.
Last May, Nephros said it inked a distribution agreement with CS Medical to distribute Nephros’ DSU-H ultrafilter as an option with CS Medical’s TD 100 automated trans-esophageal echocardiogram probe disinfector.
