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
313–336 of 798
Cleared May 11, 2005
MODIFICATION TO: MICROLIFE DIGITAL PACIFIER THERMOMETER, MODEL MT1751Q
K051100
Microlife Intellectual Property GmbH
General Hospital · 12d
Cleared Apr 27, 2005
REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, REUSABLE
K050837
Ge Healthcare
General Hospital · 26d
Cleared Mar 18, 2005
TEMPTOUCH DERMAL THERMOMETER
K050137
Xilas Medical, Inc.
General Hospital · 53d
Cleared Mar 04, 2005
DIGITAL FOREHEAD THERMOMETER, MODEL FS-100
K043331
Hubdic Co., Ltd.
General Hospital · 92d
Cleared Feb 25, 2005
5 SEC DIGITAL CLINICAL THERMOMETER, MODELS ST8630X, ST8640X, ST8730X, ST8740X, ST8930X, ST8940X, ST8030X, ST8040X.
K050303
Mesure Technology Co., Ltd.
General Hospital · 17d
Cleared Feb 16, 2005
TURBO TEMP TRIO
K050230
Cardinal Health, Alaris Products
General Hospital · 15d
Cleared Dec 22, 2004
EAR THERMOMETER, MODEL WL-320X
K042631
Innovatech, Inc.
General Hospital · 86d
Cleared Dec 09, 2004
MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT18L1
K043110
Microlife Intellectual Property GmbH
General Hospital · 29d
Cleared Nov 26, 2004
PACK & PROPER PACK & PROPER, EAR-THERMOMETER PROBE CAP
K042653
Pack & Proper Co., Ltd.
General Hospital · 59d
Cleared Nov 19, 2004
AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101
K042906
Amplife Corporation
General Hospital · 29d
Cleared Oct 18, 2004
EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65
K042627
Mesure Technology Co., Ltd.
General Hospital · 21d
Cleared Sep 30, 2004
AMPLIFE DIGITAL CLINICAL THERMOMETER
K042575
Amplife Corporation
General Hospital · 8d
Cleared Sep 13, 2004
INFRARED EAR THERMOMETER, ET-100 SERIES
K041692
Hangzhou Hua'An Medical & Health Instruments Co.,
General Hospital · 83d
Cleared Sep 13, 2004
DIGITAL FLEXIBLE THERMOMETER, BASIC DIGITAL THERMOMETER, DITITAL PACIFIER THERMOMETER
K041694
Hangzhou Hua'An Medical & Health Instruments Co.,
General Hospital · 83d
Cleared Sep 10, 2004
TEMPTELLER - HIGH SPEED DIGITAL THERMOMETERS, MODELS DT-302, DT-312, DT-412, DT-502
K042202
Oriental System Technology, Inc.
General Hospital · 28d
Cleared Sep 08, 2004
DIGITAL THERMOMETER, MODELS MT-XX8 AND MT-XX9
K041516
Vega Technologies, Inc.
General Hospital · 96d
Cleared Sep 08, 2004
DIGITAL CLINICAL THERMOMETER, MODELS ST-8A3C AND ST-8A3F
K042013
Mesure Technology Co., Ltd.
General Hospital · 43d
Cleared Jul 22, 2004
THERMOTEK Q5
K041646
Saat , Ltd.
General Hospital · 35d
Cleared May 12, 2004
10-SECOND DIGITAL THERMOMETER, MODELS ST87, ST89, ST80, ST88
K041056
Mesure Technology Co., Ltd.
General Hospital · 19d
Cleared Feb 23, 2004
MICROLIFE DIGITAL INFRARED FOREHEAD THERMOMETER, MODEL FR1DM1
K033820
Microlife Intellectual Property GmbH
General Hospital · 76d
Cleared Jan 15, 2004
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1-1
K034023
Microlife Intellectual Property GmbH
General Hospital · 17d
Cleared Jan 08, 2004
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODELS IR1DA1-2, IR1DE1-2
K033817
Microlife Intellectual Property GmbH
General Hospital · 30d
Cleared Jan 08, 2004
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODELS IR1DC1/V971, IR1DG1/SKU4289, IR1DH1/SKU4290
K033818
Microlife Intellectual Property GmbH
General Hospital · 30d
Cleared Oct 24, 2003
AVITA TS8/TS9 SERIES IR EAR/FOREHEAD THERMOMETER
K031503
Avita Corporation
General Hospital · 164d