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 Mar 29, 2013
NEXUS IR30 NON-CONTACT INFRARED FOREHEAD THERMOMETER
K122221
Taidoc Technology Corporation
General Hospital · 247d
Cleared Mar 13, 2013
VISIOFOCUS
K122412
Tecnimed S.R.L.
General Hospital · 217d
Cleared Feb 28, 2013
GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE
K121999
Draeger Medical GmbH
General Hospital · 234d
Cleared Feb 27, 2013
ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM
K123361
Fiab Spa
General Hospital · 119d
Cleared Feb 05, 2013
DIGITAL THERMOMTER
K122520
Taidoc Technology Corporation
General Hospital · 172d
Cleared Nov 19, 2012
NON-CONTACT THERMOMETER
K120711
K-Jump Health Co., Ltd.
General Hospital · 256d
Cleared Nov 07, 2012
DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER)
K122912
Hangzhou Hua'An Medical & Health Instruments Co.,
General Hospital · 47d
Cleared Oct 11, 2012
WIRELESS THERMOMETER
K121696
Raling Medical Company
General Hospital · 126d
Cleared Sep 07, 2012
INFRARED THERMOMETER
K113761
Famidoc Technology Co., Ltd.
General Hospital · 261d
Cleared Aug 23, 2012
(MULTIPLE) DIGITAL THERMOMETER
K120004
China Shenyang Med-Land Imp/Exp Corp., Ltd.
General Hospital · 233d
Cleared Jul 17, 2012
NON-CONTACT CLINICAL THERMOMETER
K121428
Radiant Innovation, Inc.
General Hospital · 64d
Cleared Jun 15, 2012
FORA COMFORTSCAN EAR THERMOMETER
K121118
Foracare, Inc.
General Hospital · 64d
Cleared Jun 06, 2012
FORA COMFORTSCAN EAR THERMOMETER
K120712
Taidoc Technology Corporation
General Hospital · 90d
Cleared May 30, 2012
3M SPOTON TEMPERATURE MONITORING SYSTEM
K120412
Arizant Healthcare, Inc.
General Hospital · 110d
Cleared May 29, 2012
UNIMED TEMPERATURE PROBE
K121427
Unimed Medical Supplies, Inc.
General Hospital · 15d
Cleared Mar 29, 2012
INFRARED EAR THEROMETER
K111703
Fudakang Industrial Co., Ltd.
General Hospital · 286d
Cleared Mar 02, 2012
E-CARE INFRARED EAR THERMOMETER
K113095
E-Care Technology Corporation
General Hospital · 135d
Cleared Feb 17, 2012
VALEO VT-601 SERIES IR THERMOMETER
K111463
Valeo Corp.
General Hospital · 267d
Cleared Jan 27, 2012
MICROLIFE DUAL MODE THERMOMETER,MODEL IFR1MJ1
K113141
Microlife Intellectual Property GmbH
General Hospital · 95d
Cleared Jan 13, 2012
THERMO PAL INFRARED EAR THERMOMETER
K112189
Digio2 International Co., Ltd.
General Hospital · 168d
Cleared Jan 06, 2012
AVITA INFRARED THEROMETER WITH BLUETOOTH
K110559
Avita Corporation
General Hospital · 312d
Cleared Jan 06, 2012
U-RIGHT TD-1240 THERMOMETER
K113159
Taidoc Technology Corporation
General Hospital · 72d
Cleared Dec 16, 2011
DISPOSABLE THERMOMETER COVERS AND SHEATHS
K112289
Kang ZE Industrial Co. Limited
General Hospital · 129d
Cleared Dec 06, 2011
INFRARED EAR THERMOMETER
K111637
Radiant Innovation, Inc.
General Hospital · 176d