510(k) K242860

Type 5 Integrating Indicator for Steam (CSPN-15) by True Indicating, LLC — Product Code JOJ

K242860 is an FDA 510(k) premarket notification submitted by True Indicating, LLC for the device "Type 5 Integrating Indicator for Steam (CSPN-15)". The FDA issued a decision of Substantially Equivalent on January 17, 2025. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. True Indicating, LLC has at least 5 other 510(k) clearances on record.