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Nephros announces FDA 510(k) submission of S100 Ultrafilter

Nephros announced that it has submitted to the US Food and Drug Administration (FDA) for 510(k) clearance, the S100 Point of Use filter designed to filter Environmental Protection Agency (EPA) quality drinking water to retain waterborne bacteria to assist in infection control.

The S100 ultrafilter is designed to assist hospitals and medical facilities with temporary protection from bacteria that may be dispersed into the water from biofilm growing in a building’s piping infrastructure.

Legionella and pseudomonas are common bacteria that can have a devastating impact on patients whose immune systems are compromised. The S100 Point of Use filter attaches to the end of a sink faucet and was designed and tested to provide 3 months of protection.

"During a waterborne pathogen outbreak, it is vital that medical professionals have the ability to quickly contain the bacteria and provide for patient safety while the building engineers and water treatment professionals undertake the arduous task of cleaning the building’s piping," said Daron Evans, President and CEO of Nephros.

"Subject to FDA clearance, the S100 will add another product to our infection control portfolio targeted at providing bacteria free water for patient washing and drinking."

Nephros is a commercial stage medical device company that develops and sells high performance liquid purification filters, as well as a hemodiafiltration system for the treatment of patients with end stage kidney disease.

Its filters, which it calls ultrafilters, are used primarily in medical applications.