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
265–288 of 798
Cleared Feb 16, 1989
CLINICAL ELECTRONIC THERMOMETERS
K884765
Sheridan Catheter Corp.
General Hospital · 94d
Cleared Nov 02, 1988
TYPE 9230 TEMP 1 & 2 SYSTEM ATHENA
K884119
S & W Medico Teknik
General Hospital · 33d
Cleared Aug 04, 1988
CLINICAL ELECTRONIC THERMOMETERS
K882127
Sheridan Catheter Corp.
General Hospital · 76d
Cleared Jul 13, 1988
CLINICAL ELECTONIC THERMOMETERS
K881368
Sheridan Catheter Corp.
General Hospital · 22d
Cleared Jul 12, 1988
DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL)
K882304
Abco Dealers, Inc.
General Hospital · 39d
Cleared Jan 29, 1988
HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE
K874514
Mallinckrodt Critical Care
General Hospital · 88d
Cleared Jan 06, 1988
HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR
K874568
Mallinckrodt Critical Care
General Hospital · 62d
Cleared Nov 06, 1987
HI-LO TEMP(R) SKIN TEMPERATURE SENSOR
K874404
Mallinckrodt Critical Care
General Hospital · 9d
Cleared Nov 03, 1987
THERMOCOUPLE ADAPTER
K873833
Mallinckrodt Critical Care
General Hospital · 43d
Cleared May 11, 1987
THERMOMETER SHEATHS
K871465
Abco Dealers, Inc.
General Hospital · 27d
Cleared Dec 01, 1986
DISPOSABLE PHARMASEAL TEMPERATURE MONITORING PROBE
K864397
American Pharmaseal Div. Ahsc
General Hospital · 25d
Cleared Feb 12, 1986
IVAC MODEL 2080 ELECTRONIC THERMOMETER
K860436
Y
General Hospital · 8d
Cleared Dec 03, 1985
TMA TEMPERATURE MONITOR
K852825
Ferguson Medical
General Hospital · 155d
Cleared Aug 16, 1985
CRAFTEMP ET 3045 ELECTRONIC THERMOMETRY SYSTEM
K852454
Gambro, Inc.
General Hospital · 67d
Cleared Aug 05, 1985
B-D DIGITAL FEVER THERMOMETER
K852954
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 25d
Cleared Jul 24, 1985
TOSHIBA DIGITAL CLINICAL THERMOMTER
K852903
Toshiba Medical Systems
General Hospital · 15d
Cleared Jun 27, 1985
CAPIOX LUER DESIGN THERMISTORS & CAPIOX CONNECTORS
K852087
Terumo Medical Corp.
General Hospital · 45d
Cleared May 10, 1985
THERMOMED
K851704
Draeger Medical, Inc.
General Hospital · 15d
Cleared Apr 04, 1985
CLINICAL ELECTRONIC THERMOMETERS
K850244
Sheridan Catheter Corp.
General Hospital · 72d
Cleared Mar 04, 1985
HI-LO TEMP THERMOCOUPLE TO THERMISTER ADAPTOR
K844201
Mallinckrodt Critical Care
General Hospital · 125d
Cleared Dec 07, 1984
TOSHIBA DIGITAL CLINICAL THERMOMETER
K844124
Toshiba Medical Systems
General Hospital · 45d
Cleared Jul 18, 1984
TERUMO DIGITAL CLINICAL THERMOMETER
K841740
Terumo Medical Corp.
General Hospital · 82d
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