510(k) K220473

CELERITY 20 HP Challenge Pack by Steris — Product Code FRC

K220473 is an FDA 510(k) premarket notification submitted by Steris for the device "CELERITY 20 HP Challenge Pack". The FDA issued a decision of Substantially Equivalent on March 18, 2022. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Steris has at least 10 other 510(k) clearances on record.