FLL · Class II · 21 CFR 880.2910

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 Microlife Intellectual Property GmbH, R & D Batteries, Inc. and Taidoc Technology Corporation.

798
Total
798
Cleared
139d
Avg days
1976
Since
798 devices
505–528 of 798
Cleared Jan 22, 1982
SERIES 400 DISPOSABLE TEMPERATURE PROBE
K813639
Yellow Springs Instrument Co., Inc.
General Hospital · 22d
Cleared Jan 12, 1982
WA-2000 TEMPERATURE INDICATOR
K813402
Wallach Surgical Devices, Inc.
General Hospital · 39d
Cleared Dec 18, 1981
MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER
K813409
Yellow Springs Instrument Co., Inc.
General Hospital · 14d
Cleared Mar 31, 1981
PROBE COVER
K810474
Narco Air-Shields
General Hospital · 36d
Cleared Feb 02, 1981
TEMPERATURE FUNCTION BLOCK
K810173
Honeywell, Inc.
General Hospital · 11d
Cleared Sep 16, 1980
SHILEY TEMPERATURE MONITOR
K802147
Shiley, Inc.
General Hospital · 11d
Cleared Sep 09, 1980
IVAC 811Y ELEC. CLINICAL THERMOMETER
K801930
Y
General Hospital · 28d
Cleared Mar 25, 1980
ELECTRONIC CLINICAL THERM. MODEL 811A
K800512
Y
General Hospital · 20d
Cleared Jan 16, 1980
YSI SERIES 500 THERMISTOR PROBES
K792116
Yellow Springs Instrument Co., Inc.
General Hospital · 83d
Cleared Aug 03, 1979
IVAC 833 ELECTRONIC THERMOMETER
K791208
Y
General Hospital · 32d
Cleared Aug 03, 1979
IVAC 819 ELECTRONIC THERMOMETER
K791209
Y
General Hospital · 32d
Cleared Aug 10, 1978
TEMPERATURE MODULE, DUAL
K781136
Cavitron Corp.
General Hospital · 34d
Cleared Aug 10, 1978
THERMOMETER, MODEL 49TA
K781312
Yellow Springs Instrument Co., Inc.
General Hospital · 10d
Cleared Jun 06, 1978
PROBE COVER
K780593
Abco Dealers, Inc.
General Hospital · 57d
Cleared Dec 13, 1977
TEMPERATURE MONITOR
K772217
Hudson Oxygen Therapy Sales Co.
General Hospital · 11d
Cleared Nov 22, 1977
ELECTROTHERM MODELS TC-100 & M-99
K771995
Electromedics, Inc.
Chemistry · 32d
Cleared Nov 22, 1977
TELETHERMOMETER MODEL T T-100
K771996
Electromedics, Inc.
Chemistry · 32d
Cleared Nov 15, 1977
TELETHERMOMETER MODEL T T-400
K771997
Electromedics, Inc.
Chemistry · 25d
Cleared Nov 15, 1977
TEMP-A-LERT MODEL TA-986
K771998
Electromedics, Inc.
Chemistry · 25d
Cleared Nov 15, 1977
ELECTROTHERM MODELS F&C18,14,78, F84
K771999
Electromedics, Inc.
Chemistry · 25d
Cleared Nov 02, 1977
ELECTROTHERM MODEL HT-1
K771994
Electromedics, Inc.
Chemistry · 12d
Cleared May 03, 1977
THERMOMETER, ELECTRONIC, DIGIMED HOL
K770777
Elmed, Inc.
General Hospital · 5d
Cleared Dec 23, 1976
SERIES 700 PATIENT MONITORS
K761244
Spacelabs, Inc.
General Hospital · 10d
Cleared Dec 09, 1976
THERMO FINER CORETEMP
K760948
Terumo America, Inc.
General Hospital · 38d