510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K093370Substantially Equivalent

Fu Hong Industries Limited Soother Teether

Fu Hong Industries, Ltd., Greenwood Village CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K093370 is the FDA 510(k) clearance record for FU HONG INDUSTRIES LIMITED SOOTHER TEETHER, a class II device, cleared for Fu Hong Industries , Ltd. on under FDA product code KKO (Ring, Teething, Fluid-Filled). FDA records list 2 510(k) clearances for Fu Hong Industries , Ltd., from to . As of , FDA records show no recalls naming K093370.

Clearance record

Decision date
Received
(84 days to decision)
Product code
KKO Ring, Teething, Fluid-Filled
Regulation
21 CFR 872.5550
Device class
Class II
Review panel
Dental
Applicant
Fu Hong Industries , Ltd. 5401 S Cottonwood Ct., Greenwood Village CO
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