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 21, 2017
Braun No Touch + Forehead NTF3000 Thermometer
K163516
Kaz USA, Inc., A Helen of Troy Company
General Hospital · 127d
Cleared Apr 19, 2017
VisioFocus Mini, VisioFocus Smart
K160680
Tecnimed S.R.L.
General Hospital · 405d
Cleared Apr 06, 2017
Dual Mode Infrared Thermometer
K163256
Intelliworks, LLC
General Hospital · 136d
Cleared Mar 10, 2017
Infrared Non-contact Thermometer, Model ACT8100
K162509
Easywell Biomedicals, Inc.
General Hospital · 183d
Cleared Feb 24, 2017
DT-100
K160358
Mediana Co., Ltd.
General Hospital · 381d
Cleared Jan 19, 2017
Fever Scout™ Continuous Monitoring thermometer
K162137
VivaLNK, Inc.
General Hospital · 171d
Cleared Jan 09, 2017
RII Multi-function Infrared Thermometer, Model TH52Z
K162083
Radiant Innovation, Inc.
General Hospital · 166d
Cleared Dec 13, 2016
Cloud Smart Thermometer
K160306
Guangzhou Bosma Technology Co, Ltd.
General Hospital · 313d
Cleared Dec 05, 2016
Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1
K161728
Microfile Intellectual Property GmbH
General Hospital · 166d
Cleared Nov 17, 2016
Non-contact Forehead Thermometer
K161735
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)
K160816
Nexmed Technology Co., Ltd.
General Hospital · 181d
Cleared Aug 29, 2016
Digital Thermometer
K161211
Biocare Asia Corporation , Ltd.
General Hospital · 123d
Cleared Aug 24, 2016
Infrared Forehead Thermometer, FT-100A
K160802
Hangzhou Universal Electronic Co., Ltd.
General Hospital · 154d
Cleared Aug 16, 2016
The Braun ThermoScan® 3 High Speed Compact Ear Thermometer
K161933
Kaz USA, Inc., A Helen of Troy Company
General Hospital · 33d
Cleared Aug 01, 2016
Infra-red forehead thermometer
K160999
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
K152905
Arc Devices Limited
General Hospital · 293d
Cleared Jul 15, 2016
Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT)
K160308
Fudakang Industrial Co., Ltd.
General Hospital · 162d
Cleared Jun 22, 2016
CliniCloud Non-contact Thermometer, Model SPL1024
K161325
Stethocloud Pty.Ltd (Clinicloud)
General Hospital · 41d
Cleared Jun 17, 2016
Withings Thermo (Model SCT01)
K160544
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
K153149
Sejoy Electronics & Instruments Co., Ltd.
General Hospital · 210d
Cleared May 20, 2016
Temperature Probe, Affinity Temperature Probe
K160091
Medtronic, Inc.
General Hospital · 126d
Cleared May 06, 2016
TD-1035 Thermometer
K152680
Taidoc Technology Corporation
General Hospital · 231d
Cleared Mar 31, 2016
Infrared Ear Thermometer
K153146
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)
K152640
Fudakang Industries Co., Ltd.
General Hospital · 195d