510(k) K260766

Celerity 5 HP Biological Indicator (LCB052) by STERIS Corporation — Product Code FRC

K260766 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "Celerity 5 HP Biological Indicator (LCB052)". The FDA issued a decision of Substantially Equivalent on April 8, 2026. 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.