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
433–456 of 798
Cleared Oct 17, 1991
BI-TEMP TEMPERATURE MONITOR TM-201D
K913083
Respiratory Support Products, Inc.
General Hospital · 147d
Cleared Aug 16, 1991
1.1, 1.2, 1.3 TEMPERATURE PROBES
K912650
Vital Signs, Inc.
General Hospital · 60d
Cleared Apr 22, 1991
TEMPERATURE WELL PROBE, TWP SERIES
K910868
Gish Biomedical, Inc.
General Hospital · 52d
Cleared Apr 09, 1991
YSI PRECISION 4000 THERMOMETER
K910718
Yellow Springs Instrument Co., Inc.
General Hospital · 48d
Cleared Feb 14, 1991
DATA RECORDER
K910118
Healthdyne, Inc.
General Hospital · 34d
Cleared Feb 07, 1991
DIGITAL THERMOMETER KITS
K905025
Abco Dealers, Inc.
General Hospital · 92d
Cleared Oct 22, 1990
KEJUMP DIGITAL CLINICAL THERMOMETER
K903590
K-Jump Health Co., Ltd.
General Hospital · 75d
Cleared Aug 30, 1990
BD FLEXIBLE DIGITAL THERMOMETER
K902624
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 77d
Cleared Mar 02, 1990
IVAC MODEL 2090 INFRA RED THERMOMETER
K896914
Y
General Hospital · 81d
Cleared Sep 05, 1989
MYOCARDIAL PROBE THERMOMETER CODE 64000
K893418
Dlp, Inc.
General Hospital · 126d
Cleared May 05, 1989
ACCESSORY TO CLINICAL ELECTRONIC THERMOMETER
K890823
Sheridan Catheter Corp.
General Hospital · 77d
Cleared Mar 08, 1989
MODEL 1000 ELECTRONIC CLINICAL THERMOMETER
K885187
Mon-A-Therm, Inc.
General Hospital · 84d
Cleared Feb 16, 1989
CLINICAL ELECTRONIC THERMOMETERS
K884765
Sheridan Catheter Corp.
General Hospital · 94d
Cleared Nov 21, 1988
DISPOSABLE TEMPERATURE PROBES (SEVERAL MODELS)
K883793
Yellow Springs Instrument Co., Inc.
General Hospital · 75d
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 Mar 01, 1988
ADAP-TEMP, MODEL: AT-100
K874694
Respiratory Support Products, Inc.
General Hospital · 109d
Cleared Jan 29, 1988
HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE
K874514
Mallinckrodt Critical Care
General Hospital · 88d
Cleared Jan 19, 1988
MON-A-THERM'S SKIN TEMPERATURE SENSOR
K875234
Mon-A-Therm, Inc.
General Hospital · 28d
Cleared Jan 14, 1988
TYMPANIC TEMPERATURE SENSOR
K873205
Respiratory Support Products, Inc.
General Hospital · 153d
Cleared Jan 06, 1988
MODIFIED AIRWAY TEMPERATURE SENSOR
K874520
Mon-A-Therm, Inc.
General Hospital · 65d
Cleared Jan 06, 1988
MODIFIED THERMAL WELL TEMPERATURE SENSOR
K874521
Mon-A-Therm, Inc.
General Hospital · 65d