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
Cleared
Sep 15, 2021
INFRARED BODY THERMOMETER (Model: YK-001)
Longnan Renzhong Medical Equipment Co., Ltd.
General Hospital
239d
Cleared
Sep 09, 2021
Electronic Thermometer (XHF2001, XHF2002)
Putian Hanjiang Huafeng Plastic Co., Ltd.
General Hospital
129d
Cleared
Sep 03, 2021
Infrared Thermometer, Model: HW-1
Dongguan Simzo Electronic Technology Co., Ltd.
General Hospital
102d
Cleared
Aug 31, 2021
PlusCare Temperature Probes, Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS, PTSW-AS, PTSM-15AS, PTSL-AS, PTMR-AS
Jkh USA, LLC
General Hospital
260d
Cleared
Aug 11, 2021
Sensatronic Reusable Temperature Probes
Sensatronic GmbH
General Hospital
240d
Cleared
Jul 28, 2021
Disposable Ear Thermometer Probe Cover
Huaian Zhongxin Packing Material Co., Ltd.
General Hospital
247d
Cleared
Jul 23, 2021
Infrared Forehead Thermometer, Model BSX976
Shenzhen Bsx Technology Electronics Co., Ltd.
General Hospital
344d
Cleared
Jul 22, 2021
Temp Pal
Iweecare Co., Ltd.
General Hospital
317d
Cleared
Jul 07, 2021
Infrared Forehead Thermometer
Shenzhen Combei Technology Co., Ltd.
General Hospital
292d
Cleared
Jun 17, 2021
Infrared Thermometer
Shenzhen Sonida Digital Technology Co., Ltd.
General Hospital
296d
Cleared
Jun 11, 2021
Radius T wearable thermometer
Masimo Corporation
General Hospital
221d
Cleared
Jun 04, 2021
Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)
Guandong Genial Technology Co., Limited
General Hospital
151d
Cleared
May 20, 2021
YUWELL infrared ear thermometer: YHT101, YHT200
Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.
General Hospital
163d
Cleared
Apr 29, 2021
Infrared Thermometer
Shandong Zhushi Pharmaceutical Group Co., Ltd.
General Hospital
157d
Cleared
Apr 16, 2021
Infrared Thermometer Models: DT-8806S, DT-8807S
Shenzhen Everbest Machinery Industry Co., Ltd.
General Hospital
175d
Cleared
Mar 31, 2021
Digital Thermometer Model T103, T104
Bioland Technology, Ltd.
General Hospital
267d
Cleared
Mar 22, 2021
Probe Cover: JZ-KBT-001, JZ-KBT-002, JZ-KBT-005, JZ-KBT-007, JZ-KBT-008, JZ-KBT-009, JZ-KBT-010, JZ-KBT-015, JZ-KBT-025, JZ-KBT-026
Shenzhen Juzhong Technology Co., Ltd.
General Hospital
244d
Cleared
Mar 12, 2021
Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603
Shenzhen Zhengkang Technology Co., Ltd.
General Hospital
84d
Cleared
Mar 09, 2021
Infrared Thermometer
Dongguan Prestige Sporting Goods Co., Ltd.
General Hospital
277d
Cleared
Mar 09, 2021
Body Infrared Thermometer HT-820D
Dongguan Xintai Instrument Co., Ltd.
General Hospital
182d
Cleared
Mar 08, 2021
iHealth Wireless No-Touch Forehead Thermometer
Andon Health Co, Ltd.
General Hospital
168d
Cleared
Feb 26, 2021
Medical infrared forehead thermometer
Hunan Honggao Electronic Technolofy Co., Ltd.
General Hospital
211d
Cleared
Feb 25, 2021
Infrared Forehead Thermometer
Conmo Electronic Company Limited
General Hospital
185d
Cleared
Feb 25, 2021
Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C
Hetaida Technology Co., Ltd.
General Hospital
105d