510(k) K220404

STERRAD NX with ALLClear Technology by Advanced Sterilization Products, Inc. — Product Code MLR

K220404 is an FDA 510(k) premarket notification submitted by Advanced Sterilization Products, Inc. for the device "STERRAD NX with ALLClear Technology". The FDA issued a decision of Substantially Equivalent on May 16, 2022. 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.