510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K092494Substantially Equivalent

Gel Filled Gum Soother

Luv N' Care Ltd, Monroe LA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K092494 is the FDA 510(k) clearance record for GEL FILLED GUM SOOTHER, a class II device, cleared for Luv N' Care, Ltd. on under FDA product code KKO (Ring, Teething, Fluid-Filled). FDA records list 2 510(k) clearances for Luv N' Care, Ltd., from to . As of , FDA records show no recalls naming K092494.

Clearance record

Decision date
Received
(199 days to decision)
Product code
KKO Ring, Teething, Fluid-Filled
Regulation
21 CFR 872.5550
Device class
Class II
Review panel
Dental
Applicant
Luv N' Care, Ltd. 3030 Aurora Ave., 2nd Floor, Monroe LA
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