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
409–432 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 Feb 15, 1994
EXTRACORPOREAL TEMPERATURE SENSOR
K935603
Smiths Industries Medical Systems, Inc.
General Hospital · 89d
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 May 26, 1993
BATTERY PACK #1014NC
K925674
Portable Power Systems, Inc.
General Hospital · 197d
Cleared May 26, 1993
BATTERY PACK #1015NC
K925675
Portable Power Systems, Inc.
General Hospital · 197d
Cleared Mar 09, 1993
ADAP-TEMP TEMPERATURE SENSOR ADAPTER
K921190
Respiratory Support Products, Inc.
General Hospital · 365d
Cleared Sep 11, 1992
MYOCARDINAL TEMPERATURE SENSOR WITH TYPE 400 SERIE
K920469
Respiratory Support Products, Inc.
General Hospital · 228d
Cleared Apr 20, 1992
ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE
K912742
Spacelabs, Inc.
General Hospital · 304d
Cleared Jan 28, 1992
MODEL TM101 TEMPERATURE MONITOR
K902386
Fisher & Paykel Electronics , Ltd.
General Hospital · 608d
Cleared Dec 11, 1991
BI-TEMP TEMPERATURE MONITOR,MODEL TM-300D
K913082
Respiratory Support Products, Inc.
General Hospital · 202d
Cleared Oct 17, 1991
BI-TEMP TEMPERATURE MONITOR, MODEL TM-400D
K912280
Respiratory Support Products, Inc.
General Hospital · 147d