510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K181986Substantially Equivalent

Klinly Ultrasonic Tongue Cleaner

Kea Products, Ltd., Kwun Tong, HK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K181986 is the FDA 510(k) clearance record for Klinly Ultrasonic Tongue Cleaner, a class I device, cleared for Kea Products, Ltd. on under FDA product code QIA (Powered Tongue Scraper). FDA's definition for product code QIA reads: "The device is intended to remove debris from the top surface of the tongue as a supplement to normal daily oral hygiene care". FDA records list one 510(k) clearance for Kea Products, Ltd. As of , FDA records show no recalls naming K181986.

Clearance record

Decision date
Received
(408 days to decision)
Product code
QIA Powered Tongue Scraper
Regulation
21 CFR 872.6865
Device class
Class I
Review panel
Dental
Applicant
Kea Products, Ltd. 10c, Meyer Ind. Bldg, 2 Chong Yip St., Kwun Tong, HK
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QIA

Trailing 12 months

FDA records hold no clearances under product code QIA in the trailing twelve months.

FDA records show no clearances under product code QIA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QIA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260