510(k) K252680

Celerity™ 20 HP Biological Indicator by STERIS Corporation — Product Code FRC

K252680 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "Celerity™ 20 HP Biological Indicator". The FDA issued a decision of Substantially Equivalent on September 24, 2025. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. STERIS Corporation has at least 10 other 510(k) clearances on record.