510(k) K192025

STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader by Advanced Sterilization Products (Asp) — Product Code FRC

K192025 is an FDA 510(k) premarket notification submitted by Advanced Sterilization Products (Asp) for the device "STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader". The FDA issued a decision of Substantially Equivalent on January 23, 2020. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Advanced Sterilization Products (Asp) has at least 4 other 510(k) clearances on record.