VitaSmart Hypothermic Oxygenated Perfusion System

VitaSmart Hypothermic Oxygenated Perfusion System is an FDA 510(k)-cleared medical device (DEN250009) manufactured by Bridge TO Life, Ltd.. 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 January 14, 2026. Regulation: 8.