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
241–264 of 798
Cleared Aug 18, 1995
R&D BATTERIES PART NOS. 5064, 5157, 5489 AND 5536
K951400
R & D Batteries, Inc.
General Hospital · 143d
Cleared Aug 18, 1995
R&D BATTERIES PART NOS. 5015, 5016, 5037 AND 5051
K951401
R & D Batteries, Inc.
General Hospital · 143d
Cleared Aug 18, 1995
R&D BATTERIES PART NOS. 5167, 5221, 5244 AND 5247
K951402
R & D Batteries, Inc.
General Hospital · 143d
Cleared Aug 18, 1995
R&D BATTERIES PART NOS. 5164, 5252, 5634 AND 5650
K951403
R & D Batteries, Inc.
General Hospital · 143d
Cleared Aug 18, 1995
R&D BATTERIES PART NOS. 5096, 5115, 5128 AND 5131
K951404
R & D Batteries, Inc.
General Hospital · 143d
Cleared Aug 17, 1994
B-D DIGITAL THERMOMETER
K935267
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 288d
Cleared Jul 08, 1994
ELECTRONIC THERMOMETERS
K940686
American Diagnostic Corp.
General Hospital · 142d
Cleared May 02, 1994
VITAL SIGNS DUAL DISPLAY TEMPERATURE MONITOR, MODEL 1600
K934482
Vital Signs, Inc.
General Hospital · 230d
Cleared Apr 08, 1994
EXAC-TEMP & CLINI-TEMP TYMPANIC & MYOCARDIAL PROBE
K925792
Deroyal Industries, Inc.
General Hospital · 508d
Cleared Mar 07, 1994
ELECTROMEDICS TYMPANIC TEMPERATURE SENSOR
K934964
Electromedics, Inc.
General Hospital · 143d
Cleared Feb 25, 1994
EXAC-TEMP & CLINI-TEMP PROBE W/TEMPERATURE SENSOR
K925791
Deroyal Industries, Inc.
General Hospital · 466d
Cleared Jan 28, 1994
ELECTROMEDICS HG (HYDROGEL) SERIES SKIN TEMPERATURE SENSOR
K933832
Electromedics, Inc.
General Hospital · 176d
Cleared Jan 10, 1994
R & D BATTERIES, INC. PART # 5003, 5198, 5253
K933642
R & D Batteries, Inc.
General Hospital · 167d
Cleared Jun 29, 1993
MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA
K915633
S & W Medico Teknik
General Hospital · 609d
Cleared Jun 29, 1993
OMRON TYMPANIC THERMOMETER MC-500
K922344
Omron Healthcare, Inc.
General Hospital · 406d
Cleared Apr 20, 1992
ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE
K912742
Spacelabs, Inc.
General Hospital · 304d
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 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 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