NxStage System One with NxView

NxStage System One with NxView is an FDA 510(k)-cleared medical device (K252377) manufactured by Fresenius Medical Care Renal Therapies Group, LLC. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 14, 2026. Regulation: 8.