ONE TRAY® Sealed Sterilization Container System

ONE TRAY® Sealed Sterilization Container System is an FDA 510(k)-cleared medical device (K250029) manufactured by Innovative Sterilization Technologies. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 30, 2025. Regulation: 8.