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
265–288 of 798
Cleared Oct 18, 2011
THERMOFLASH(TM) INFRARED THERMOMETER
K112929
Visiomed Group SA
General Hospital · 15d
Cleared Oct 04, 2011
DIGITAL CLINICAL THERMOMETER MODEL V901US
K112116
Amperor-Electronic(Sz) Co., Ltd.
General Hospital · 71d
Cleared Oct 04, 2011
SHAKER DIGITAL THERMOMETER
K112703
Measure Technology Co. , Ltd.
General Hospital · 18d
Cleared Aug 31, 2011
S-CATH ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM
K112376
Circa Scientific, LLC
General Hospital · 14d
Cleared Aug 24, 2011
DIGITAL THERMOMETER MT SERIES
K110776
Sejoy Electronics & Instruments Co., Ltd.
General Hospital · 156d
Cleared Aug 15, 2011
ION HEALTH USB INSTA-SCAN THERMOMETER
K111974
Taidoc Technology Corporation
General Hospital · 34d
Cleared Aug 11, 2011
DISPOSABLE TEMPERATURE PROBES / SENSORS AND INTERCONNECT INSTRUMENT CABLES
K111282
Starboard Medical, LLC
General Hospital · 97d
Cleared Jul 18, 2011
MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSOR
K110956
Medivance, Inc.
General Hospital · 104d
Cleared Jun 06, 2011
BEHIND EAR GENTLE TOUCH THERMOMETER
K103839
Kaz, Inc.
General Hospital · 158d
Cleared May 13, 2011
COTRONIC DIGITAL THERMOMETER
K103407
Cotronic Manufacturing
General Hospital · 175d
Cleared Apr 06, 2011
MICROLIFE DIGITAL UNDERARM THERMOMETER
K103680
Microlife Intellectual Property GmbH
General Hospital · 110d
Cleared Apr 04, 2011
DIGITAL FOREHEAD THERMOMETER
K103617
K-Jump Health Co., Ltd.
General Hospital · 115d
Cleared Mar 03, 2011
AVITA SCANEO IR THERMOMETER MODEL TS4X SERIES
K102554
Avita Corporation
General Hospital · 177d
Cleared Feb 25, 2011
NON-CONTACT INFRARED THERMOMETER
K102947
K-Jump Health Co., Ltd.
General Hospital · 144d
Cleared Jan 26, 2011
BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES CLINICAL INFRARED EAR THERMOMETERS
K103800
Kaz USA, Inc (A Subsidiaryof Kaz Inc)
General Hospital · 29d
Cleared Jul 22, 2010
IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081
K100488
Shenzhen Dongdixin Technology Co., Ltd.
General Hospital · 153d
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 Mar 04, 2010
AVITA SCANEO INFRARED EAR THERMOMETER, MODEL TS7
K100016
Avita Corporation
General Hospital · 59d
Cleared Dec 02, 2009
AVITA SCANEO IR THERMOMETER, MODELS TS2X & TS3X SERIES
K092958
Avita Corporation
General Hospital · 68d
Cleared Nov 27, 2009
AVITA RADAR THERMO IR THERMOMETER, MODEL NT 152
K092959
Avita Corporation
General Hospital · 63d
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