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
217–240 of 798
Cleared Mar 23, 2016
VDT985US Vicks SmartTemp Thermometer
K152975
Kaz USA, Inc., A Helen of Troy Company
General Hospital · 167d
Cleared Mar 04, 2016
IRTS Thermal Imaging Probe (TIP)
K152402
Securus,Inc
General Hospital · 192d
Cleared Mar 01, 2016
Braun Thermoscan PRO 6000 Ear Thermometer
K152748
Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc)
General Hospital · 160d
Cleared Feb 09, 2016
Electronic Thermometer
K152739
Guangdong Biolight Meditech Co., Ltd.
General Hospital · 139d
Cleared Jan 15, 2016
DISPOSABLE THERMOMETER PROBE SHEATHS
K152690
Pinghu Sama Medical Packing Co., Ltd.
General Hospital · 116d
Cleared Dec 31, 2015
Ageless Health Medical Digital Thermometer
K152508
Dongguan Ageless Health Industrial Co., Ltd.
General Hospital · 120d
Cleared Oct 20, 2015
Temple Touch Pro (TTP) Non-invasive temperature monitoring system
K150160
Medisim, Ltd.
General Hospital · 270d
Cleared Sep 02, 2015
TempTraq TT-100
K143267
Blue Spark Technologies, Inc.
General Hospital · 293d
Cleared Aug 26, 2014
BASAL DIGITAL THERMOMETER
K141505
K-Jump Health Co., Ltd.
General Hospital · 81d
Cleared Aug 21, 2014
BELTER INFRA-RED EAR THERMOMETER
K140681
Shenzhen Belter Health Measurement and Analysis TE
General Hospital · 156d
Cleared Jul 08, 2014
WIRELESS THERMOMETER
K132761
Raiing Medical Company
General Hospital · 307d
Cleared May 21, 2014
NO TOUCH+FOREHEAD NTF 3000 THERMOMETER
K134043
Kaz USA, Inc (A Subsidiaryof Kaz Inc)
General Hospital · 141d
Cleared Mar 18, 2014
ELECTRONIC THERMOMETER
K131210
Shenzhen Pump Medical System Co., Ltd.
General Hospital · 323d
Cleared Feb 21, 2014
FORA DIAMOND NEXUS MINI INFRARED FOREHEAD THERMOMETER
K132457
Biocare Asia Corporation , Ltd.
General Hospital · 199d
Cleared Feb 04, 2014
DUTECK(MICHEALTH)DIGITAL CLINICAL THERMOMETER
K132140
Duteck Industrial Co., Ltd.
General Hospital · 208d
Cleared Dec 26, 2013
KINGTECH DIGITAL THERMOMETER
K133111
Kingtech Enterprise, Ltd.
General Hospital · 87d
Cleared Dec 26, 2013
KINGTECH FOREHEAD THERMOMETER
K133113
Kingtech Enterprise, Ltd.
General Hospital · 87d
Cleared Dec 02, 2013
KINSA SMART THERMOMETER
K132514
Kinsa, Inc.
General Hospital · 112d
Cleared Nov 12, 2013
NON-CONTACT INFRARED THERMOMETER
K131243
Shenzhen Jumper Medical Equipment Co., Ltd.
General Hospital · 195d
Cleared Oct 15, 2013
NON-CONTACT INFRARED THERMOMETER
K130231
Jinxinbao Electronic Co.,Ltd
General Hospital · 259d
Cleared Oct 07, 2013
CAREGIVER PROFESSIONAL CLINICAL THERMOMETER, PRO-TF SERIES
K131771
Thermomedics, Inc.
General Hospital · 112d
Cleared Aug 28, 2013
UGFT3
K131155
Medisim, Ltd.
General Hospital · 126d
Cleared May 17, 2013
DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03)
K120671
Cotronic Technology Limited
General Hospital · 438d
Cleared Apr 02, 2013
THERMOFINDER
K130361
Hubdic Co., Ltd.
General Hospital · 48d