FDA Product Code FLL: Continuous Measurement Thermometer
Under FDA product code FLL, continuous measurement thermometers are cleared for ongoing body temperature monitoring in clinical settings.
Unlike intermittent spot-check thermometers, these devices provide a continuous temperature reading through sustained contact with the patient — typically via a skin patch, rectal probe, or esophageal sensor — enabling real-time detection of fever onset and temperature trends in critically ill patients.
FLL devices are Class II medical devices, regulated under 21 CFR 880.2910 and reviewed by the FDA General Hospital panel.
Leading manufacturers include Andon Health Co, Ltd., Alicn Medical (Shenzhen), Inc. and Shenzhen AOJ Medical Technology Co., Ltd..
FDA 510(k) Cleared Continuous Measurement Thermometer Devices (Product Code FLL)
About Product Code FLL - Regulatory Context
510(k) Submission Activity
797 total 510(k) submissions under product code FLL since 1976, with 797 receiving FDA clearance (average review time: 139 days).
Submission volume has declined in recent years - 13 submissions in the last 24 months compared to 31 in the prior period.
FDA Review Time
Recent submissions under FLL have taken an average of 189 days to reach a decision - up from 138 days historically. Manufacturers should account for longer review timelines in current project planning.
FLL devices are reviewed by the General Hospital panel. Browse all General Hospital devices →