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
481–504 of 798
Cleared Jul 18, 1984
TYCOS SELF-CHECK/DIGITAL FEVER THERMO
K842132
Sybron Corp.
General Hospital · 49d
Cleared Jun 05, 1984
TEMPROBE MONITOR
K840648
Vital Signs, Inc.
General Hospital · 111d
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
TEMP TRACE
K830530
Progress Mankind Technology
General Hospital · 47d
Cleared Apr 06, 1983
MODIFICATION ELECTRONIC CLINICAL THERMO-
K830819
Mon-A-Therm, Inc.
General Hospital · 22d
Cleared Apr 06, 1983
AMER. 400 SERIES TEMP. PROBES-RECTALL
K830839
American Pharmaseal Div. Ahsc
General Hospital · 21d
Cleared Mar 24, 1983
DISPOSABLE TEMP. PROBE & CABLE MODELS
K830561
Yellow Springs Instrument Co., Inc.
General Hospital · 29d
Cleared Mar 17, 1983
LUER LOCK TEMPERATURE SENSOR
K830552
Mon-A-Therm, Inc.
General Hospital · 22d
Cleared Jan 12, 1983
MODEL 400 & 700 TEMP. SENSOR ADAPTERS
K823333
Mon-A-Therm, Inc.
General Hospital · 65d
Cleared Nov 24, 1982
HEART RATE & TEMP. MEASUREMENT SYSTEM
K822939
Camino Laboratories, Inc.
General Hospital · 51d
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 Jun 23, 1982
THERMAL WELL TEMPERATURE SENSOR
K821504
Mon-A-Therm, Inc.
General Hospital · 34d
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