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., Taidoc Technology Corporation and Masimo Corporation.
List of Continuous Measurement Thermometer devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Continuous Measurement Thermometer devices (product code FLL). 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 →