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
337–360 of 798
Cleared Sep 23, 2003
MICROLIFE DIGITAL UNDERARM ELECTRONIC THERMOMETER, MODEL MT 18E1 (V932)
K032364
Microlife Intellectual Property GmbH
General Hospital · 54d
Cleared Sep 11, 2003
MICROLIFE MODEL MT18E1-1 (V932-1) DIGITAL UNDERARM ELECTRONIC THERMOMETER
K032658
Microlife Intellectual Property GmbH
General Hospital · 14d
Cleared Aug 15, 2003
MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL QT1JA1
K031958
Microlife Intellectual Property GmbH
General Hospital · 51d
Cleared May 06, 2003
SURETEMP PLUS
K030580
Welch Allyn, Inc.
General Hospital · 71d
Cleared Jul 17, 2002
DIGITAL CLINICAL THERMOMETER, MODEL KD-193
K021851
K-Jump Health Co., Ltd.
General Hospital · 42d
Cleared May 02, 2002
HIVOX EAR THERMOMETER, TS SERIES
K020471
Hivox Biotek, Inc.
General Hospital · 79d
Cleared Sep 10, 2001
AVITA AGIL IT 101 INSTANT DIGITAL THERMOMETER
K012136
Avita Corporation
General Hospital · 63d
Cleared Apr 11, 2001
AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)
K010462
Avita Corporation
General Hospital · 54d
Cleared Dec 29, 2000
AVITA TSO/TS1 INFRARED EAR THERMOMETER
K002182
Avita Corporation
General Hospital · 163d
Cleared Aug 23, 2000
CECILIA PENGUIN MULTI-USE THERMOMETER, MODEL HP-ETO9999
K993950
Nien Made Electrnics Corp.
General Hospital · 275d
Cleared Apr 12, 2000
A&D MEDICAL UT-101 LIFESOURCE DIGITAL EAR THEROMETER
K993116
A&D Engineering, Inc.
General Hospital · 205d
Cleared Jan 14, 2000
INFRARED EAR THERMOMETER, MODEL KI-8120
K984551
K-Jump Health Co., Ltd.
General Hospital · 388d
Cleared Oct 27, 1999
TEMP TELLER - DIGITAL THERMOMETER, MODELS DT-101, DT-102, DT-103, DT-201, DT-202, DT-203
K992601
Oriental System Technology, Inc.
General Hospital · 85d
Cleared Oct 20, 1999
BRAUN THERMOSCAN PRO3000 INFARED THERMOMETER
K992468
Braun GmbH
General Hospital · 89d
Cleared Oct 06, 1999
SUPER SOOTHER
K991914
Mart Tiller Corp.
General Hospital · 121d
Cleared Aug 18, 1999
DUTECK DIGITAL CLINICAL THERMOMETER
K992327
Duteck Industrial Co., Ltd.
General Hospital · 37d
Cleared Jul 29, 1999
SD-100 SKYEAR THERMOMETER
K984506
Skylark Device Co., Ltd.
General Hospital · 223d
Cleared May 26, 1999
TEMP TELLER-INFRARED TYMPANIC THERMOMETER, MODELS TT-200, TT-201
K984497
Oriental System Technology, Inc.
General Hospital · 160d
Cleared Mar 23, 1999
DR180-R/OXY
K983576
North East Monitoring, Inc.
General Hospital · 161d
Cleared Mar 15, 1999
BRAUN THERMOSCAN IRT3020/3500 ONE SECONS EAR THERMOMETER, MODEL IRT3020/3520
K983295
Braun AG
General Hospital · 175d
Cleared Mar 12, 1999
SABRATEK APM-2000 AMBULATORY PATIENT MONTOR, TRANSCUTANEOUS TEMPERATURE MONITOR
K983355
Sabratek Corp.
General Hospital · 170d
Cleared Feb 25, 1999
MICROLIFE IT2CA1
K990168
Microlife Systems AG
General Hospital · 37d
Cleared Feb 12, 1999
UP-GRADE AND UP-GRADE PRO
K983887
Medisim, Ltd.
General Hospital · 102d
Cleared Jan 14, 1999
TALKING DIGITAL THERMOMETER, MODEL KV-171
K984553
K-Jump Health Co., Ltd.
General Hospital · 23d