510(k) K192001

Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device by Sterilucent, Inc. — Product Code FRC

K192001 is an FDA 510(k) premarket notification submitted by Sterilucent, Inc. for the device "Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device". The FDA issued a decision of Substantially Equivalent on October 22, 2019. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Sterilucent, Inc. has at least 6 other 510(k) clearances on record.