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
289–312 of 798
Cleared Mar 10, 2009
FORA IR20B EAR THERMOMETER, MODEL TD-1261F, FORA IR21B EAR THERMOMETER, MODEL TD-1261E
K090395
Taidoc Technology Corporation
General Hospital · 21d
Cleared Feb 26, 2009
FORA IR22 EAR THERMOMETER, MODEL TD-1262
K090294
Taidoc Technology Corporation
General Hospital · 21d
Cleared Dec 10, 2008
TAIDOC TD-11 SERIES AND CLEVER TD-1112 EAR/SKIN/ SURFACE IR THERMOMETERS & FORA IR16/17 EAR THERMOMETER
K083299
Taidoc Technology Corporation
General Hospital · 30d
Cleared Aug 11, 2008
FORA COMFORTSCAN EAR THERMOMETER, MODELS TD-1261A
K081445
Taidoc Technology Corporation
General Hospital · 81d
Cleared Jun 24, 2008
AVITA RADAR THERMO IR THERMOMETER, NT1 SERIES
K081160
Avita Corporation
General Hospital · 62d
Cleared Apr 02, 2008
FORA COMFORT 4 IN 1 EAR THERMOMETER, MODEL TD-1116
K080593
Taidoc Technology Corporation
General Hospital · 30d
Cleared Feb 08, 2008
TALKING CLINICAL ELECTRONIC THERMOMETER, MODELS DX6623B, DT1031 AND DT1041
K073366
Shenzhen Dongdixin Technology Co., Ltd.
General Hospital · 70d
Cleared Sep 11, 2007
MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT19S1R
K070590
Microlife Intellectual Property GmbH
General Hospital · 194d
Cleared Jun 21, 2007
DIGITAL FOREHEAD THERMOMETER, MODEL# KD-2200
K070491
K-Jump Health Co., Ltd.
General Hospital · 121d
Cleared Feb 02, 2007
ACON DIGITAL THERMOMETER PROBE COVERS
K063418
ACON Laboratories, Inc.
General Hospital · 81d
Cleared Dec 06, 2006
MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL QT1JC1
K062867
Microlife Intellectual Property GmbH
General Hospital · 72d
Cleared Sep 29, 2006
TYMPANIC TEMPERATURE PROBE WITH FOAM, MODEL M1024233
K061942
Ge Healthcare
General Hospital · 81d
Cleared Jul 07, 2006
CLEVER TD-1112 EAR/SKIN/SURFACE IR THERMOMETER
K061800
Taidoc Technology Corporation
General Hospital · 11d
Cleared May 19, 2006
K-JUMP DIGITAL THERMOMETER WITH BATTERY-LESS PATCH, MODEL KD-2100
K060240
K-Jump Health Co., Ltd.
General Hospital · 108d
Cleared Mar 17, 2006
ACON 30 SECOND RELIABLE DIGITAL THERMOMETER, ACON DIGITAL THERMOMETER PROBE COVERS
K060173
ACON Laboratories, Inc.
General Hospital · 53d
Cleared Feb 06, 2006
SEJOY, MODEL MT-403
K051699
Sejoy Electronics & Instruments Co., Ltd.
General Hospital · 227d
Cleared Jan 17, 2006
PROTON PHC 8731 10 SECOND DIGITAL THERMOMETER
K051566
Proton Healthcare , Ltd.
General Hospital · 217d
Cleared Sep 23, 2005
NPAC MULTI-USE EAR THERMOMETER, MODELS TP 700,TP 702
K051835
Norm Pacific Automation Corp.
General Hospital · 79d
Cleared Sep 20, 2005
DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBES
K051873
Ge Healthcare
General Hospital · 71d
Cleared Sep 09, 2005
RII INFRARED EAR THERMOMETER, MODELS TH00XY SERIES
K051269
Radiant Innovation, Inc.
General Hospital · 115d
Cleared Sep 07, 2005
INFRARED EAR THEMOMETER, MODELS DX6603, DX66390
K051251
Shenzhen Dongdixin Technology Co., Ltd.
General Hospital · 114d
Cleared Sep 01, 2005
DUAL MODE UP-GRADE FOREHEAD/UNDERARM THERMOMETER DEVICE
K051422
Medisim, Ltd.
General Hospital · 92d
Cleared Jul 27, 2005
CLEVER TD-1107 EAR/SKIN/SURFACE IR THERMOMETER, CLEVER TD-1110 EAR/SKIN/SURFACE IR THERMOMETER
K050463
Taidoc Technology Corporation
General Hospital · 154d
Cleared Jun 21, 2005
OMRON MODEL 514N TYMPANIC THERMOMETER
K051233
Omron Healthcare, Inc.
General Hospital · 39d