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
289–312 of 798
Cleared Mar 27, 1984
SHILEY DISPOS. TEMP. PROBES
K833981
Shiley, Inc.
General Hospital · 131d
Cleared Oct 04, 1983
HI-LO TEMP TYMPANIC TEMP. SENSOR
K832635
Mallinckrodt Critical Care
General Hospital · 61d
Cleared Sep 12, 1983
RECTAL TEMP. TELEMETRY MONITOR
K832404
Xomed, Inc.
General Hospital · 54d
Cleared Aug 24, 1983
TEMPERATURE MODULE 242-100
K831733
Kontron Instruments, Inc.
General Hospital · 85d
Cleared Aug 12, 1983
LME TEMP. MONITOR
K832042
Litton Medical Electronics
General Hospital · 49d
Cleared May 18, 1983
DISPOS. TYPE T THERMOCOUPLE TEMP.PROBE
K830592
Electromedics, Inc.
General Hospital · 83d
Cleared Apr 06, 1983
AMER. 400 SERIES TEMP. PROBES-RECTALL
K830839
American Pharmaseal Div. Ahsc
General Hospital · 21d
Cleared Nov 17, 1982
DESERT INSYTE-A HYPERTHERMIA SENSOR ACC
K823066
Parke-Davis Co.
General Hospital · 30d
Cleared Oct 28, 1982
RI 300 DIFFERENTIAL TEMPERATURE MONITOR
K822831
Instrumentation Industries, Inc.
General Hospital · 37d
Cleared Jul 28, 1982
DESERET INSYTE HYPERTHERMIA CATHETER
K821886
Warner-Lambert Co.
General Hospital · 33d
Cleared Jul 20, 1982
HI-LO TEMP SKIN TEMPERATURE SENSOR
K821833
Mallinckrodt Critical Care
General Hospital · 28d
Cleared May 14, 1982
DISPOSABLE TEMPERATURE PROBE
K821244
Shiley, Inc.
General Hospital · 15d
Cleared Mar 26, 1982
REUSABLE & DISPOSABLE TEMP. PROBES
K813459
Electromedics, Inc.
General Hospital · 115d
Cleared Mar 02, 1982
ELECTRONIC CLINICAL THERMOMETER TEMP PR
K820409
Y
General Hospital · 18d
Cleared Jan 28, 1982
CONPHAR DIGITAL THERMOMETER
K813306
Conphar, Inc.
General Hospital · 66d
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 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 Jun 06, 1978
PROBE COVER
K780593
Abco Dealers, Inc.
General Hospital · 57d
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