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
193–216 of 798
Cleared Apr 06, 2011
MICROLIFE DIGITAL UNDERARM THERMOMETER
K103680
Microlife Intellectual Property GmbH
General Hospital · 110d
Cleared May 26, 2010
U-RIGHT EAR THEMOMETER, MODELS TD-1115 AND TD-1118
K100942
Taidoc Technology Corporation
General Hospital · 51d
Cleared May 17, 2010
MICROLIFE NON-CONTACT INFRARED FOREHEAD THERMOMETER, MODEL FR1DZ1
K100953
Microlife Intellectual Property GmbH
General Hospital · 41d
Cleared Sep 01, 2009
MC-245, MC-246, MC-247, MC-341, MC-343, MC-344
K091676
Omron Healthcare, Inc.
General Hospital · 84d
Cleared Jun 10, 2009
MICROLIFE DIGITAL ELECTRONIC THERMOMETER, MODEL MT16K1
K091589
Microlife Intellectual Property GmbH
General Hospital · 8d
Cleared May 13, 2009
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IRIDVI-1
K091040
Microlife Intellectual Property GmbH
General Hospital · 30d
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 Apr 02, 2008
FORA COMFORT 4 IN 1 EAR THERMOMETER, MODEL TD-1116
K080593
Taidoc Technology Corporation
General Hospital · 30d
Cleared Sep 11, 2007
MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT19S1R
K070590
Microlife Intellectual Property GmbH
General Hospital · 194d
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 Mar 17, 2006
ACON 30 SECOND RELIABLE DIGITAL THERMOMETER, ACON DIGITAL THERMOMETER PROBE COVERS
K060173
ACON Laboratories, Inc.
General Hospital · 53d
Cleared Sep 20, 2005
DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBES
K051873
Ge Healthcare
General Hospital · 71d
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
Cleared May 11, 2005
MODIFICATION TO: MICROLIFE DIGITAL PACIFIER THERMOMETER, MODEL MT1751Q
K051100
Microlife Intellectual Property GmbH
General Hospital · 12d
Cleared Apr 27, 2005
REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, REUSABLE
K050837
Ge Healthcare
General Hospital · 26d
Cleared Dec 09, 2004
MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT18L1
K043110
Microlife Intellectual Property GmbH
General Hospital · 29d
Cleared Feb 23, 2004
MICROLIFE DIGITAL INFRARED FOREHEAD THERMOMETER, MODEL FR1DM1
K033820
Microlife Intellectual Property GmbH
General Hospital · 76d