Cleared Special

K080981 - EAR THERMOMETER, MODELS ST66 AND ST67

K080981 is an FDA 510(k) clearance for EAR THERMOMETER, manufactured by Mesure Technology Co., Ltd.. The device is a Class 2 General Hospital device with product code FLL cleared through the Special 510(k) pathway after a 25-day FDA review.

K080981 · Mesure Technology Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
25d
Days
Class 2
Risk

K080981 is an FDA 510(k) clearance for the EAR THERMOMETER, MODELS ST66 AND ST67. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Mesure Technology Co., Ltd. (San Chung City, TW). The FDA issued a Cleared decision on May 2, 2008 after a review of 25 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2910 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K080981

510(k) Number K080981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2008
Decision Date May 02, 2008
Days to Decision 25 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 129d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

FLL Device Classification - Class 2, Special Controls

Product Code FLL Continuous Measurement Thermometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2910
Definition A Continuous Measurement Thermometer Is A Clinical Electronic Thermometer Indicated To Measure The Body Or Skin Temperature Of A Person Continuously Or In Specified Intervals. Under This Regulation, This Product Code Represents Non-exempt Devices. For More Information, See 90 Fr 25889, Available At Https://www.govinfo.gov/content/pkg/fr-2025-06-18/pdf/2025-11207.pdf.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FLL Continuous Measurement Thermometer

All 695
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K080981.
WIRELESS BODY TEMPERATURE MONITOR, MODELS BTM-DIC, D, E, F, G AND H
K081256 · Rio Flexon Technology Co., Ltd. · May 2008
THERMOFLASH LX-26
K080759 · Jxb Co. Ltd Guangzhou (China) · May 2008
TEMPTOUCH DERMAL THERMOMETER
K081162 · Diabetica Solutions, Inc. · May 2008
FORA COMFORT 4 IN 1 EAR THERMOMETER, MODEL TD-1116
K080593 · Taidoc Technology Corporation · Apr 2008
TALKING CLINICAL ELECTRONIC THERMOMETER, MODELS DX6623B, DT1031 AND DT1041
K073366 · Shenzhen Dongdixin Technology Co., Ltd. · Feb 2008
CLINICAL ELECTRONIC THERMOMETERS, MODEL(S) MT901, MT518, ECT-1
K072635 · Ningbo Huahui Medical Instruments Co., Ltd. · Jan 2008
K080981 · EAR THERMOMETER, MODELS ST66 AND ST67
Download PDF FDA Summary Mesure Technology Co.…