510(k) K252843

STERRAD 100NX Sterilization System with ALLClear Technology (10104) by Advanced Sterilization Products, Inc. — Product Code MLR

K252843 is an FDA 510(k) premarket notification submitted by Advanced Sterilization Products, Inc. for the device "STERRAD 100NX Sterilization System with ALLClear Technology (10104)". The FDA issued a decision of Substantially Equivalent on April 15, 2026. The device falls under product code MLR (Sterilizer, Chemical), a Class II device regulated under 21 CFR 880.6860. Advanced Sterilization Products, Inc. has at least 10 other 510(k) clearances on record.