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
217–240 of 798
Cleared Jan 15, 2004
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1-1
K034023
Microlife Intellectual Property GmbH
General Hospital · 17d
Cleared Jan 08, 2004
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODELS IR1DA1-2, IR1DE1-2
K033817
Microlife Intellectual Property GmbH
General Hospital · 30d
Cleared Jan 08, 2004
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODELS IR1DC1/V971, IR1DG1/SKU4289, IR1DH1/SKU4290
K033818
Microlife Intellectual Property GmbH
General Hospital · 30d
Cleared Sep 23, 2003
MICROLIFE DIGITAL UNDERARM ELECTRONIC THERMOMETER, MODEL MT 18E1 (V932)
K032364
Microlife Intellectual Property GmbH
General Hospital · 54d
Cleared Sep 11, 2003
MICROLIFE MODEL MT18E1-1 (V932-1) DIGITAL UNDERARM ELECTRONIC THERMOMETER
K032658
Microlife Intellectual Property GmbH
General Hospital · 14d
Cleared Aug 15, 2003
MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL QT1JA1
K031958
Microlife Intellectual Property GmbH
General Hospital · 51d
Cleared May 06, 2003
SURETEMP PLUS
K030580
Welch Allyn, Inc.
General Hospital · 71d
Cleared Jul 03, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS61010
K971866
Alexander Mfg. Co.
General Hospital · 44d
Cleared Apr 02, 1997
ALEXANDER MANUFACTURING COMPANY
K970271
Alexander Mfg. Co.
General Hospital · 69d
Cleared Oct 01, 1996
MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT THERMOMETER
K955846
Y
General Hospital · 280d
Cleared Dec 20, 1995
OLYMPIC INFANT THERMOMETER
K954434
Olympic Medical Corp.
General Hospital · 86d
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