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