DuoprossTM Smart Cap (Type I)

DuoprossTM Smart Cap (Type I) is an FDA 510(k)-cleared medical device (K252518) manufactured by Duopross Meditech Corporate. 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 December 16, 2025. Regulation: 8.