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 Alicn Medical (Shenzhen), Inc., Joytech Healthcare Co. , Ltd. and Shenzhen AOJ Medical Technology Co., Ltd..

798
Total
798
Cleared
139d
Avg days
1976
Since
798 devices
121–144 of 798
Cleared Jul 08, 2020
Digital Thermometer
K200599
Joytech Healthcare Co. , Ltd.
General Hospital · 121d
Cleared Jun 19, 2020
Infrared Thermometer Model Number RN-60A,RN-60B
K200471
Ningbo Ranor Medical Science & Technology Co., Ltd.
General Hospital · 114d
Cleared Jun 17, 2020
Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503
K193253
Shenzhen Changkun Technology Co., Ltd.
General Hospital · 212d
Cleared Apr 28, 2020
Vicks VNT200 No Touch Forehead Thermometer
K193213
Kaz USA, Inc., A Helen of Troy Company
General Hospital · 159d
Cleared Apr 22, 2020
Infrared Forehead Thermometer
K190984
Xiamen Ants Bro Technology Co., Ltd.
General Hospital · 373d
Cleared Feb 13, 2020
Microlife Non-Contact Infrared Forehead Thermometer
K191829
Microlife Intellectual Property GmbH
General Hospital · 219d
Cleared Dec 31, 2019
Digital Thermometer
K190990
Xiamen Ants Bro Technology Co., Ltd.
General Hospital · 260d
Cleared Dec 13, 2019
Infrared Thermometer, model: PC808
K190717
Shenzhen Pacom Medical Instruments Co., Ltd.
General Hospital · 268d
Cleared Nov 18, 2019
Digital Thermometer
K183393
Joytech Healthcare Co. , Ltd.
General Hospital · 346d
Cleared Nov 13, 2019
Infrared Thermometer Model MD-H30
K191570
Guangzhou Berrcom Medical Device Co., Ltd.
General Hospital · 153d
Cleared Oct 18, 2019
Infrared Thermometer, Breeze model
K191283
Suzhou Melodicare Medical Technology Co., Ltd.
General Hospital · 158d
Cleared Oct 18, 2019
Infrared Forehead Thermometer (Model IR-FT)
K191668
Comper Chuangxiang (Beijing) Technology Co., Ltd.
General Hospital · 119d
Cleared Oct 15, 2019
Infared Thermometer
K191251
Shenzhen Calibeur Industries Co., Ltd.
General Hospital · 159d
Cleared Oct 10, 2019
ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System
K192210
Fiab Spa
General Hospital · 57d
Cleared Sep 06, 2019
Reusable Temperature Probe
K182751
Shenzhen Caremed Medical Technology Co., Ltd.
General Hospital · 343d
Cleared Sep 05, 2019
Advocate Non-Contact Infrared Thermometer
K191004
Broadmaster Biotech, Corp.
General Hospital · 142d
Cleared Jul 26, 2019
Infrared Ear/Forehead Thermometer
K190873
Joytech Healthcare Co. , Ltd.
General Hospital · 114d
Cleared Jul 16, 2019
Microlife Digital Infrared Ear Thermometer
K183663
Microlife Intellectual Property GmbH
General Hospital · 201d
Cleared Jun 18, 2019
Med-link Temperature Probes
K182667
Shenzhen Med-Link Electronics Tech Co., Ltd.
General Hospital · 266d
Cleared Jun 14, 2019
Medline Digital Rectal Thermometer Sheath
K183431
Medline Industries, Inc.
General Hospital · 185d
Cleared May 05, 2019
Wireless Intelligent Thermometer
K182437
Shenzhen Jumper Medical Equipment Co., Ltd.
General Hospital · 240d
Cleared Apr 03, 2019
Infrared thermometer
K182597
Shenzhen Pango Electronic Co., Ltd.
General Hospital · 195d
Cleared Mar 27, 2019
Tyto Thermometer
K190242
Tyto Care , Ltd.
General Hospital · 49d
Cleared Feb 28, 2019
Digital Thermometer
K182629
Joytech Healthcare Co. , Ltd.
General Hospital · 157d