510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K123855Substantially Equivalent

Water-Filled Teether

Solid Toys Ind. Ltd., Bonita Springs FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123855 is the FDA 510(k) clearance record for WATER-FILLED TEETHER, a class II device, cleared for Solid Toys Ind. , Ltd. on under FDA product code KKO (Ring, Teething, Fluid-Filled). FDA records list one 510(k) clearance for Solid Toys Ind. , Ltd. As of , FDA records show no recalls naming K123855.

Clearance record

Decision date
Received
(161 days to decision)
Product code
KKO Ring, Teething, Fluid-Filled
Regulation
21 CFR 872.5550
Device class
Class II
Review panel
Dental
Applicant
Solid Toys Ind. , Ltd. 24301 Woodsage Dr., Bonita Springs FL
510(k) summary
Summary PDF
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