510(k) K251122

Terragene® Bionova® BT20 Biological Indicator by Terragene — Product Code FRC

K251122 is an FDA 510(k) premarket notification submitted by Terragene for the device "Terragene® Bionova® BT20 Biological Indicator". The FDA issued a decision of Substantially Equivalent on August 4, 2025. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Terragene has at least 8 other 510(k) clearances on record.