510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080981Substantially Equivalent

Ear Thermometer, Models St66 and St67

Mesure Technology Co., Ltd., San Chung City, TW / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080981 is the FDA 510(k) clearance record for EAR THERMOMETER, MODELS ST66 AND ST67, a class II device, cleared for Mesure Technology Co., Ltd. on under FDA product code FLL (Continuous Measurement Thermometer). FDA's definition for product code FLL reads: "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...". FDA records list 13 510(k) clearances for Mesure Technology Co., Ltd., from to . As of , FDA records show no recalls naming K080981.

Clearance record

Decision date
Received
(25 days to decision)
Product code
FLL Continuous Measurement Thermometer
Regulation
21 CFR 880.2910
Device class
Class II
Review panel
General Hospital
Applicant
Mesure Technology Co., Ltd. 7f,# 86,Sec.1, Kwang Fu Rd., San Chung City, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FLL

Trailing 12 months
2 clearances under product code FLL in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FLL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260