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
385–408 of 798
Cleared Sep 12, 1996
BASIS BABY-TEMP PACIFIER DIGITAL THEROMETER
K962991
Polymedica Industries, Inc.
General Hospital · 42d
Cleared Aug 20, 1996
TALKING DIGITAL THERMOMETER
K962369
Ultmost Industrial Corp.
General Hospital · 62d
Cleared Aug 20, 1996
SENSOR SHEATH TS1
K962386
Radiotherapeutics Corp.
General Hospital · 61d
Cleared Aug 16, 1996
PRO-FLEX, DIGITAL THERMOMETER WITH FLEXIBLE PROBE
K961357
Intelligent Product Limited Co.
General Hospital · 130d
Cleared Aug 15, 1996
ENDOCARE ELECTORNIC THERMOMETER SYSTEM
K961365
Endocare, Inc.
General Hospital · 128d
Cleared Jul 19, 1996
YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBE
K962070
Yellow Springs Instrument Co., Inc.
General Hospital · 52d
Cleared Jun 21, 1996
LUMISCOPE MODEL 2018 THERMOMETER
K954792
Lumiscope Co., Inc.
General Hospital · 247d
Cleared Jun 10, 1996
ELECTRONIC THERMOMETER
K961879
Wiltec Industries , Ltd.
General Hospital · 26d
Cleared Jan 02, 1996
PACIFIER THERMOMETER
K952541
Regitar U.S.A., Inc.
General Hospital · 249d
Cleared Dec 20, 1995
OLYMPIC INFANT THERMOMETER
K954434
Olympic Medical Corp.
General Hospital · 86d
Cleared Sep 22, 1995
BASIS DIGITAL THERMOMETER
K952159
Polymedica Industries, Inc.
General Hospital · 137d
Cleared Aug 18, 1995
R&D BATTRIES, INC. PART NUMBERS 5601, 5602, 5624 AND 5626
K951274
R & D Batteries, Inc.
General Hospital · 150d
Cleared Aug 18, 1995
R&D BATTERIES, INC. PART NUMBERS 5453, 5474, 5513 AND 5595
K951275
R & D Batteries, Inc.
General Hospital · 150d
Cleared Aug 18, 1995
R&D BATTERIES, INC. PART NUMBERS 5412, 5420, 5436 AND 5438
K951276
R & D Batteries, Inc.
General Hospital · 150d
Cleared Aug 18, 1995
R&D BATTERIES, INC. PART NUMBERS 5295, 5334, 5344 AND 5410
K951277
R & D Batteries, Inc.
General Hospital · 150d
Cleared Aug 18, 1995
R&D BATTERIES, INC. PART NUMBERS 5213, 5222, 5268 AND 5284
K951278
R & D Batteries, Inc.
General Hospital · 150d
Cleared Aug 18, 1995
R&D BATTEERIES, INC. PART NUMBERS 5173, 5178, 5197 AND 5199
K951279
R & D Batteries, Inc.
General Hospital · 150d
Cleared Aug 18, 1995
R&D BATTERIES, INC. PART NUMBERS 5003, 5006, 5008 AND 5012
K951280
R & D Batteries, Inc.
General Hospital · 150d
Cleared Aug 18, 1995
R&D BATTERIS, INC. PART NUMBER 5024, 5027, 5033 AND 5035
K951281
R & D Batteries, Inc.
General Hospital · 150d
Cleared Aug 18, 1995
R&D BATTERIES, INC. PART NUMBERS 5039, 5052, 5056 AND 5061
K951282
R & D Batteries, Inc.
General Hospital · 150d
Cleared Aug 18, 1995
R&D BATTERIES, INC. PART NUMBERS 5075-B, 5076, 5122 AND 5123
K951283
R & D Batteries, Inc.
General Hospital · 150d
Cleared Aug 18, 1995
R&D BATTERIES, INC. PART NUMBERS 5137, 5140, 5142 AND 5155
K951284
R & D Batteries, Inc.
General Hospital · 150d
Cleared Aug 18, 1995
R&D BATTERIES, INC. PART NUMBERS 5158, 5168, 5171 AND 5172
K951285
R & D Batteries, Inc.
General Hospital · 150d
Cleared Aug 18, 1995
R&D BATTERIES PART NOS. 5041 & 5655
K951399
R & D Batteries, Inc.
General Hospital · 143d