510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K112189Substantially Equivalent

Thermo Pal Infrared Ear Thermometer

Digio2 International Co., Ltd., Flagstaff AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112189 is the FDA 510(k) clearance record for THERMO PAL INFRARED EAR THERMOMETER, a class II device, cleared for Digio2 International 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 3 510(k) clearances for Digio2 International Co., Ltd., from to . As of , FDA records show no recalls naming K112189.

Clearance record

Decision date
Received
(168 days to decision)
Product code
FLL Continuous Measurement Thermometer
Regulation
21 CFR 880.2910
Device class
Class II
Review panel
General Hospital
Applicant
Digio2 International Co., Ltd. 2904 N. Boldt Dr., Flagstaff AZ
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