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
Cleared
Apr 21, 2017
Braun No Touch + Forehead NTF3000 Thermometer
Kaz USA, Inc., A Helen of Troy Company
General Hospital
127d
Cleared
Apr 19, 2017
VisioFocus Mini, VisioFocus Smart
Tecnimed S.R.L.
General Hospital
405d
Cleared
Apr 06, 2017
Dual Mode Infrared Thermometer
Intelliworks, LLC
General Hospital
136d
Cleared
Mar 10, 2017
Infrared Non-contact Thermometer, Model ACT8100
Easywell Biomedicals, Inc.
General Hospital
183d
Cleared
Feb 24, 2017
DT-100
Mediana Co., Ltd.
General Hospital
381d
Cleared
Jan 19, 2017
Fever Scout™ Continuous Monitoring thermometer
VivaLNK, Inc.
General Hospital
171d
Cleared
Jan 09, 2017
RII Multi-function Infrared Thermometer, Model TH52Z
Radiant Innovation, Inc.
General Hospital
166d
Cleared
Dec 13, 2016
Cloud Smart Thermometer
Guangzhou Bosma Technology Co, Ltd.
General Hospital
313d
Cleared
Dec 05, 2016
Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1
Microfile Intellectual Property GmbH
General Hospital
166d
Cleared
Nov 17, 2016
Non-contact Forehead Thermometer
Shenzhen Dongdixin Technology Co., Ltd.
General Hospital
147d
Cleared
Sep 21, 2016
Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)
Nexmed Technology Co., Ltd.
General Hospital
181d
Cleared
Aug 29, 2016
Digital Thermometer
Biocare Asia Corporation , Ltd.
General Hospital
123d
Cleared
Aug 24, 2016
Infrared Forehead Thermometer, FT-100A
Hangzhou Universal Electronic Co., Ltd.
General Hospital
154d
Cleared
Aug 16, 2016
The Braun ThermoScan® 3 High Speed Compact Ear Thermometer
Kaz USA, Inc., A Helen of Troy Company
General Hospital
33d
Cleared
Aug 01, 2016
Infra-red forehead thermometer
Hangzhou Hua'An Medical&Health Instruments Co.,Ltd
General Hospital
112d
Cleared
Jul 20, 2016
ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer
Arc Devices Limited
General Hospital
293d
Cleared
Jul 15, 2016
Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT)
Fudakang Industrial Co., Ltd.
General Hospital
162d
Cleared
Jun 22, 2016
CliniCloud Non-contact Thermometer, Model SPL1024
Stethocloud Pty.Ltd (Clinicloud)
General Hospital
41d
Cleared
Jun 17, 2016
Withings Thermo (Model SCT01)
Withings
General Hospital
112d
Cleared
May 27, 2016
Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36
Sejoy Electronics & Instruments Co., Ltd.
General Hospital
210d
Cleared
May 20, 2016
Temperature Probe, Affinity Temperature Probe
Medtronic, Inc.
General Hospital
126d
Cleared
May 06, 2016
TD-1035 Thermometer
Taidoc Technology Corporation
General Hospital
231d
Cleared
Mar 31, 2016
Infrared Ear Thermometer
Sejoy Electronics & Instruments Co., Ltd.
General Hospital
153d
Cleared
Mar 28, 2016
Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT)
Fudakang Industries Co., Ltd.
General Hospital
195d