FDA Product Code MED: Sterilant, Medical Devices
FDA product code MED covers medical device sterilants used for the chemical sterilization of heat-sensitive instruments and equipment.
These liquid sterilant solutions — typically glutaraldehyde, peracetic acid, or hydrogen peroxide-based — achieve high-level disinfection or sterilization of endoscopes, surgical instruments, and other devices that cannot withstand steam sterilization temperatures.
MED devices are Class II medical devices, regulated under 21 CFR 880.6885 and reviewed by the FDA General Hospital panel.
Leading manufacturers include STERIS Corporation.
FDA 510(k) Cleared Sterilant, Medical Devices Devices (Product Code MED)
About Product Code MED - Regulatory Context
510(k) Submission Activity
64 total 510(k) submissions under product code MED since 1988, with 64 receiving FDA clearance (average review time: 270 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 3 in the prior period.
FDA Review Time
Recent submissions under MED have taken an average of 313 days to reach a decision - up from 269 days historically. Manufacturers should account for longer review timelines in current project planning.
MED devices are reviewed by the General Hospital panel. Browse all General Hospital devices →