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.
List of Sterilant, Medical Devices devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Sterilant, Medical Devices devices (product code MED). 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 →