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
361–384 of 798
Cleared Dec 08, 1998
CLINICAL ELECTRONIC THERMOMETER
K982140
Valeo Corp.
General Hospital · 174d
Cleared Nov 02, 1998
BARCHENS COMPANY DIGITAL PACIFIER THERMOMETER
K983619
Barchens Co.
General Hospital · 18d
Cleared Oct 19, 1998
SANITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR MERCURY THERMOMETER, SENITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR
K983406
Banta Healthcare Group, Ltd.
General Hospital · 21d
Cleared Sep 30, 1998
DIGITAL CLINICAL THERMOMETER, MODELS ST-833A & ST-834A
K981337
Mesure Technology
General Hospital · 170d
Cleared Jul 23, 1998
DENTAL PORCELAIN-VARIOUS
K981708
Excel Porcelain Products
General Hospital · 87d
Cleared Jul 02, 1998
BABY PACIFIER DIGITAL THERMOMETER
K981456
K-Jump Health Co., Ltd.
General Hospital · 70d
Cleared May 07, 1998
QUICK CHECK INSTANT THERMOMETER
K971831
Ejb Medical, Inc.
General Hospital · 356d
Cleared May 01, 1998
B-D ASSURE EAR THERMOMETER
K971994
Becton Dickinson Consumer Products
General Hospital · 337d
Cleared Feb 04, 1998
FLEXIBLE TIP DIGITAL THERMOMETER
K974195
K-Jump Health Co., Ltd.
General Hospital · 89d
Cleared Jul 10, 1997
PRO CHECK DIGITAL PACIFIER THERMOMETER
K972259
Micro Weiss Electronics
General Hospital · 23d
Cleared Jul 09, 1997
ESCORT II CLINICAL THERMOMETRY MODULE (CTM)
K970011
Medical Data Electronics
General Hospital · 188d
Cleared Jul 03, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS61010
K971866
Alexander Mfg. Co.
General Hospital · 44d
Cleared May 16, 1997
BRAUN THERMOSCAN PRO-2000 INSTANT THERMOMETER (PRO-2000)
K964605
Thermoscan, Inc.
General Hospital · 179d
Cleared May 02, 1997
BASIS FLEXIBLE TIP DIGITAL THERMOMETER
K971045
Polymedica Industries, Inc.
General Hospital · 42d
Cleared Apr 02, 1997
ALEXANDER MANUFACTURING COMPANY
K970271
Alexander Mfg. Co.
General Hospital · 69d
Cleared Feb 03, 1997
ENTRACARE THERMOMTER MODEL 1000
K964851
Entracare Corp.
General Hospital · 62d
Cleared Jan 09, 1997
SURETEMP
K964643
Diatek Instruments, Inc.
General Hospital · 58d
Cleared Dec 10, 1996
THERMOSCAN INSTANT THERMOMETER MODEL IR-6000
K954523
Thermoscan, Inc.
General Hospital · 438d
Cleared Dec 06, 1996
THE SAFETY 1ST DIGITAL PACIFIER
K963276
Safety 1st, Inc.
General Hospital · 108d
Cleared Nov 19, 1996
ZOMED PASSIVE TEMPERATURE PROBE
K964286
Zomed Intl.
General Hospital · 22d
Cleared Oct 18, 1996
GEON ELECTRONIC THERMOMETER
K952001
Geon Corp.
General Hospital · 539d
Cleared Oct 08, 1996
Q-TIPS, FAICHNEY, PRIVATE LABEL
K962497
Faichney Medical Co.
General Hospital · 104d
Cleared Oct 01, 1996
MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT THERMOMETER
K955846
Y
General Hospital · 280d
Cleared Sep 12, 1996
DIGITAL CLINICAL THERMOMETER ST-813A, ST-814A, ST-823 AND ST-823A
K962520
Mesure Technology
General Hospital · 77d