510(k) K251452

Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) by Steris — Product Code FRC

K251452 is an FDA 510(k) premarket notification submitted by Steris for the device "Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)". The FDA issued a decision of Substantially Equivalent on June 6, 2025. 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.