# K092494: Gel Filled Gum Soother

- Pathway: 510(k) (Traditional)
- Applicant: Luv N' Care, Ltd.
- Decided: Mar 1, 2010 after 199 days
- Product code: KKO (Ring, Teething, Fluid-Filled)
- Device class: 2
- Regulation: 21 CFR 872.5550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The intended use or purpose of the Device is to provide a teething child with a cool soothing effect on the gums when the Device is chewed upon.

Source page: https://510kreport.com/device/K092494
Methodology: https://510kreport.com/methodology