510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K031094Substantially Equivalent

Fluid Filled Teethers

Royal King Infant Products Co., Ltd., Krathumbaen, Samutsakor, TH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K031094 is the FDA 510(k) clearance record for FLUID FILLED TEETHERS, a class II device, cleared for Royal King Infant Products Co. , Ltd. on under FDA product code KKO (Ring, Teething, Fluid-Filled). FDA records list one 510(k) clearance for Royal King Infant Products Co. , Ltd. As of , FDA records show no recalls naming K031094.

Clearance record

Decision date
Received
(245 days to decision)
Product code
KKO Ring, Teething, Fluid-Filled
Regulation
21 CFR 872.5550
Device class
Class II
Review panel
Dental
Applicant
Royal King Infant Products Co. , Ltd. 73/4 M00 1 Khaelie, Krathumbaen, Samutsakor, TH
510(k) summary
Statement
Third party review
No

Clearances, product code KKO

Trailing 12 months

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

FDA records show no clearances under product code KKO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KKO, 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