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
73–96 of 798
Cleared Sep 15, 2021
INFRARED BODY THERMOMETER (Model: YK-001)
K210118
Longnan Renzhong Medical Equipment Co., Ltd.
General Hospital · 239d
Cleared Sep 09, 2021
Electronic Thermometer (XHF2001, XHF2002)
K211352
Putian Hanjiang Huafeng Plastic Co., Ltd.
General Hospital · 129d
Cleared Sep 03, 2021
Infrared Thermometer, Model: HW-1
K211583
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
K203636
Jkh USA, LLC
General Hospital · 260d
Cleared Aug 11, 2021
Sensatronic Reusable Temperature Probes
K203643
Sensatronic GmbH
General Hospital · 240d
Cleared Jul 28, 2021
Disposable Ear Thermometer Probe Cover
K203431
Huaian Zhongxin Packing Material Co., Ltd.
General Hospital · 247d
Cleared Jul 23, 2021
Infrared Forehead Thermometer, Model BSX976
K202296
Shenzhen Bsx Technology Electronics Co., Ltd.
General Hospital · 344d
Cleared Jul 22, 2021
Temp Pal
K202603
Iweecare Co., Ltd.
General Hospital · 317d
Cleared Jul 07, 2021
Infrared Forehead Thermometer
K202741
Shenzhen Combei Technology Co., Ltd.
General Hospital · 292d
Cleared Jun 17, 2021
Infrared Thermometer
K202440
Shenzhen Sonida Digital Technology Co., Ltd.
General Hospital · 296d
Cleared Jun 11, 2021
Radius T wearable thermometer
K203215
Masimo Corporation
General Hospital · 221d
Cleared Jun 04, 2021
Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)
K210014
Guandong Genial Technology Co., Limited
General Hospital · 151d
Cleared May 20, 2021
YUWELL infrared ear thermometer: YHT101, YHT200
K203583
Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.
General Hospital · 163d
Cleared Apr 29, 2021
Infrared Thermometer
K203454
Shandong Zhushi Pharmaceutical Group Co., Ltd.
General Hospital · 157d
Cleared Apr 16, 2021
Infrared Thermometer Models: DT-8806S, DT-8807S
K203170
Shenzhen Everbest Machinery Industry Co., Ltd.
General Hospital · 175d
Cleared Mar 31, 2021
Digital Thermometer Model T103, T104
K201879
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
K202009
Shenzhen Juzhong Technology Co., Ltd.
General Hospital · 244d
Cleared Mar 12, 2021
Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603
K203707
Shenzhen Zhengkang Technology Co., Ltd.
General Hospital · 84d
Cleared Mar 09, 2021
Infrared Thermometer
K201508
Dongguan Prestige Sporting Goods Co., Ltd.
General Hospital · 277d
Cleared Mar 09, 2021
Body Infrared Thermometer HT-820D
K202591
Dongguan Xintai Instrument Co., Ltd.
General Hospital · 182d
Cleared Mar 08, 2021
iHealth Wireless No-Touch Forehead Thermometer
K202753
Andon Health Co, Ltd.
General Hospital · 168d
Cleared Feb 26, 2021
Medical infrared forehead thermometer
K202111
Hunan Honggao Electronic Technolofy Co., Ltd.
General Hospital · 211d
Cleared Feb 25, 2021
Infrared Forehead Thermometer
K202420
Conmo Electronic Company Limited
General Hospital · 185d
Cleared Feb 25, 2021
Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C
K203332
Hetaida Technology Co., Ltd.
General Hospital · 105d