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
Cleared
Aug 18, 1995
R&D BATTERIES PART NOS. 5064, 5157, 5489 AND 5536
R & D Batteries, Inc.
General Hospital
143d
Cleared
Aug 18, 1995
R&D BATTERIES PART NOS. 5015, 5016, 5037 AND 5051
R & D Batteries, Inc.
General Hospital
143d
Cleared
Aug 18, 1995
R&D BATTERIES PART NOS. 5167, 5221, 5244 AND 5247
R & D Batteries, Inc.
General Hospital
143d
Cleared
Aug 18, 1995
R&D BATTERIES PART NOS. 5164, 5252, 5634 AND 5650
R & D Batteries, Inc.
General Hospital
143d
Cleared
Aug 18, 1995
R&D BATTERIES PART NOS. 5096, 5115, 5128 AND 5131
R & D Batteries, Inc.
General Hospital
143d
Cleared
Aug 17, 1994
B-D DIGITAL THERMOMETER
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital
288d
Cleared
Jul 08, 1994
ELECTRONIC THERMOMETERS
American Diagnostic Corp.
General Hospital
142d
Cleared
May 02, 1994
VITAL SIGNS DUAL DISPLAY TEMPERATURE MONITOR, MODEL 1600
Vital Signs, Inc.
General Hospital
230d
Cleared
Apr 08, 1994
EXAC-TEMP & CLINI-TEMP TYMPANIC & MYOCARDIAL PROBE
Deroyal Industries, Inc.
General Hospital
508d
Cleared
Mar 07, 1994
ELECTROMEDICS TYMPANIC TEMPERATURE SENSOR
Electromedics, Inc.
General Hospital
143d
Cleared
Feb 25, 1994
EXAC-TEMP & CLINI-TEMP PROBE W/TEMPERATURE SENSOR
Deroyal Industries, Inc.
General Hospital
466d
Cleared
Feb 15, 1994
EXTRACORPOREAL TEMPERATURE SENSOR
Smiths Industries Medical Systems, Inc.
General Hospital
89d
Cleared
Jan 28, 1994
ELECTROMEDICS HG (HYDROGEL) SERIES SKIN TEMPERATURE SENSOR
Electromedics, Inc.
General Hospital
176d
Cleared
Jan 10, 1994
R & D BATTERIES, INC. PART # 5003, 5198, 5253
R & D Batteries, Inc.
General Hospital
167d
Cleared
Jun 29, 1993
MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA
S & W Medico Teknik
General Hospital
609d
Cleared
Jun 29, 1993
OMRON TYMPANIC THERMOMETER MC-500
Omron Healthcare, Inc.
General Hospital
406d
Cleared
May 26, 1993
BATTERY PACK #1014NC
Portable Power Systems, Inc.
General Hospital
197d
Cleared
May 26, 1993
BATTERY PACK #1015NC
Portable Power Systems, Inc.
General Hospital
197d
Cleared
Mar 09, 1993
ADAP-TEMP TEMPERATURE SENSOR ADAPTER
Respiratory Support Products, Inc.
General Hospital
365d
Cleared
Sep 11, 1992
MYOCARDINAL TEMPERATURE SENSOR WITH TYPE 400 SERIE
Respiratory Support Products, Inc.
General Hospital
228d
Cleared
Apr 20, 1992
ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE
Spacelabs, Inc.
General Hospital
304d
Cleared
Jan 28, 1992
MODEL TM101 TEMPERATURE MONITOR
Fisher & Paykel Electronics , Ltd.
General Hospital
608d
Cleared
Dec 11, 1991
BI-TEMP TEMPERATURE MONITOR,MODEL TM-300D
Respiratory Support Products, Inc.
General Hospital
202d
Cleared
Oct 17, 1991
BI-TEMP TEMPERATURE MONITOR, MODEL TM-400D
Respiratory Support Products, Inc.
General Hospital
147d