FDA Product Code MLR: Sterilizer, Chemical
Under FDA product code MLR, chemical sterilizers are cleared for the sterilization of heat-sensitive medical instruments and endoscopes.
These systems use gaseous or liquid chemical agents — including ethylene oxide, hydrogen peroxide plasma, and peracetic acid — to achieve sterilization of devices that would be damaged by the high temperatures of steam autoclaving.
MLR devices are Class II medical devices, regulated under 21 CFR 880.6860 and reviewed by the FDA General Hospital panel.
Leading manufacturers include Steris, STERIS Corporation and Advanced Sterilization Products.
List of Sterilizer, Chemical devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Sterilizer, Chemical devices (product code MLR). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the General Hospital FDA review panel. Browse all General Hospital devices →