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
145–168 of 798
Cleared Jan 22, 2019
FEMON Banana Thermometer
K180767
Life Science Technology, Inc.
General Hospital · 305d
Cleared Jan 10, 2019
Advocate Non-Contact Infrared Thermometer
K180355
Broadmaster Biotech, Corp.
General Hospital · 336d
Cleared Jan 10, 2019
Infrared Ear Thermometer
K180387
Hetaida Technology Co., Ltd.
General Hospital · 332d
Cleared Jan 02, 2019
Infrared Thermometer
K181215
Shenzhen Finicare Co., Ltd.
General Hospital · 240d
Cleared Dec 21, 2018
Disposable Temperature Probe
K182755
Shenzhen Caremed Medical Technology Co., Ltd.
General Hospital · 84d
Cleared Dec 10, 2018
Disposable Temperature Probe
K181967
Shenzhen Launch Electrical Co., Ltd.
General Hospital · 140d
Cleared Dec 06, 2018
RII Smart IR Thermometer
K163601
Radiant Innovation, Inc.
General Hospital · 715d
Cleared Dec 06, 2018
No-contact Forehead Thermometer
K173048
Dongguan Simzo Electronic Technology Co., Ltd.
General Hospital · 434d
Cleared Nov 30, 2018
welloStationX
K180298
Wello, Inc.
General Hospital · 301d
Cleared Nov 28, 2018
Non-contact Infrared Thermometer
K180207
Alicn Medical (Shenzhen), Inc.
General Hospital · 308d
Cleared Nov 20, 2018
Infrared Thermometer
K182133
Shenzhen AOJ Medical Technology Co., Ltd.
General Hospital · 106d
Cleared Nov 20, 2018
COCET Digital Thermometer (Models KFT-01/KFT-02/KFT-03/KFT-04/KFT-05/KFT-06/KFT-07/KFT-08/KFT-09/KFT-10
K182652
Kangfu Medical Equipment Factory
General Hospital · 57d
Cleared Nov 08, 2018
ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System
K180047
Fiab Spa
General Hospital · 304d
Cleared Oct 29, 2018
Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer
K181239
Joytech Healthcare Co. , Ltd.
General Hospital · 172d
Cleared Oct 25, 2018
Swaive Thermometer SWT1A
K170723
E-Care Technology Co., Ltd.
General Hospital · 595d
Cleared Oct 22, 2018
TD-1035 Thermometer
K172733
Taidoc Technology Corporation
General Hospital · 406d
Cleared Oct 10, 2018
Temperature Probe
K173194
Orantech, Inc.
General Hospital · 373d
Cleared Oct 02, 2018
Infrared Ear Thermometer
K181081
Joytech Healthcare Co. , Ltd.
General Hospital · 161d
Cleared Sep 24, 2018
Probe Covers for Thermometers
K180714
K-Jump Health Co., Ltd.
General Hospital · 189d
Cleared Aug 21, 2018
Fever Scout
K181013
VivaLNK, Inc.
General Hospital · 126d
Cleared Aug 14, 2018
Vicks RapidRead Digital Thermometer
K180131
Kaz USA, Inc., A Helen of Troy Company
General Hospital · 209d
Cleared Aug 08, 2018
Ageless Health Medical Digital Thermometer
K172508
Ageless Health Industrial Co., Ltd.
General Hospital · 352d
Cleared Jul 23, 2018
Non-contact infrared body thermometer
K171888
Hetaida Technology Co., Ltd.
General Hospital · 392d
Cleared Jul 23, 2018
Braun BNT400 No Touch + Forehead Thermometer
K181242
Kaz USA, Inc., A Helen of Troy Company
General Hospital · 74d