# K043033: Global Treasures Fluid Filled Teether

- Pathway: 510(k) (Traditional)
- Applicant: Global Treasure Industries, Ltd.
- Decided: Mar 22, 2005 after 139 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
Longest line of descent: 1 generation back to K031094 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031094: Fluid Filled Teethers, Royal King Infant Products Co., Ltd. (2003) Summary page 1.

## Indications for use
The intended use of the fluid filled teether is to help to relieve the teething discomfort of teething infants by providing a cool soothing effect. The Global Fluid Filled Teether is intended for over-the-counter use.

Source page: https://510kreport.com/device/K043033
Methodology: https://510kreport.com/methodology