Rio Vial-to-Bag Drug Reconstitution Device

Rio Vial-to-Bag Drug Reconstitution Device is an FDA 510(k)-cleared medical device (K192154) manufactured by Icu Medical. 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 19, 2020. Regulation: 8.