510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K002066Substantially Equivalent

Freezer Teether

Cool Baby, Inc., Edmond OK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002066 is the FDA 510(k) clearance record for FREEZER TEETHER, a class II device, cleared for Cool Baby, Inc. on under FDA product code KKO (Ring, Teething, Fluid-Filled). FDA records list one 510(k) clearance for Cool Baby, Inc. As of , FDA records show no recalls naming K002066.

Clearance record

Decision date
Received
(81 days to decision)
Product code
KKO Ring, Teething, Fluid-Filled
Regulation
21 CFR 872.5550
Device class
Class II
Review panel
Dental
Applicant
Cool Baby, Inc. 17620 Cranbrook Rd., Edmond OK
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