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, Midmark Corporation and W&H Sterilization S.R.L..
FDA 510(k) Cleared Sterilizer, Steam Devices (Product Code FLE)
About Product Code FLE - Regulatory Context
510(k) Submission Activity
184 total 510(k) submissions under product code FLE since 1977, with 184 receiving FDA clearance (average review time: 185 days).
Submission volume has declined in recent years - 6 submissions in the last 24 months compared to 15 in the prior period.
FDA Review Time
FDA review times for FLE submissions have been consistent, averaging 168 days recently vs 185 days historically.
FLE devices are reviewed by the General Hospital panel. Browse all General Hospital devices →