Celerity™ 20 HP Biological Indicator

Celerity™ 20 HP Biological Indicator is an FDA 510(k)-cleared medical device (K252680) manufactured by STERIS Corporation. 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 September 23, 2025. Regulation: 8.