FDA Product Code FLE: Sterilizer, Steam
Steam sterilization is the most widely used method for processing reusable surgical instruments. FDA product code FLE covers steam sterilizers — autoclaves — used in healthcare settings.
These pressure vessels use saturated steam at elevated temperature and pressure to achieve sterilization of metal instruments, textiles, and compatible materials. Modern autoclaves include gravity displacement and vacuum-assisted cycles for different load types.
FLE devices are Class II medical devices, regulated under 21 CFR 880.6880 and reviewed by the FDA General Hospital panel.
Leading manufacturers include STERIS Corporation and Steris.
List of Sterilizer, Steam devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Sterilizer, Steam devices (product code FLE). 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 →