BD - Earth day 2024

Nephros Receives FDA 510(k) Clearance of HydraGuard(TM) 10" UltraFilter

Wednesday, December 28, 2016

Nephros, Inc., a commercial stage medical device company that develops and sells high performance liquid purification ultrafilters and an on-line mid-dilution hemodiafiltration ("HDF") system for use with a hemodialysis machine for the treatment of patients with end stage renal disease, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") to market its HydraGuard™ 10" UltraFilter.

The HydraGuard™ 10" UltraFilter is designed to provide hospitals and medical facilities with a long term solution to protect patients from bacteria that may be present in the potable water systems. Legionella and pseudomonas are common bacteria that can have a devastating impact on patients whose immune systems are compromised. The HydraGuard™ 10" UltraFilter cartridge is used with a durable 10" filter housing and provides up to 6 months of life for equipment such as ice machines, endoscope re-processors and surgical humidifiers.

"The HydraGuard is a powerful addition to our infection control portfolio, with the potential to significantly aid our customers in their constant battle against Legionella and other water borne pathogens," said Daron Evans, President and CEO of Nephros. "With its 5 nanometer protection, its six month life, and its low annual cost versus competitive products, we believe the HydraGuard will set a new standard in performance and customer expectations."