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 Advanced Sterilization Products, Inc., Steris and Lowtem Co., Ltd..
FDA 510(k) Cleared Sterilizer, Chemical Devices (Product Code MLR)
About Product Code MLR - Regulatory Context
510(k) Submission Activity
47 total 510(k) submissions under product code MLR since 1994, with 47 receiving FDA clearance (average review time: 212 days).
Submission volume has declined in recent years - 5 submissions in the last 24 months compared to 7 in the prior period.
FDA Review Time
FDA review times for MLR submissions have been consistent, averaging 222 days recently vs 211 days historically.
MLR devices are reviewed by the General Hospital panel. Browse all General Hospital devices →