510(k) K251991

SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213) by Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. — Product Code JOJ

K251991 is an FDA 510(k) premarket notification submitted by Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. for the device "SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)". The FDA issued a decision of Substantially Equivalent on December 23, 2025. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. has at least 2 other 510(k) clearances on record.