# K031094: Fluid Filled Teethers

- Pathway: 510(k) (Traditional)
- Applicant: Royal King Infant Products Co., Ltd.
- Decided: Dec 8, 2003 after 245 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K043033: Global Treasures Fluid Filled Teether (2005), 0 descendants of its own

## Indications for use
The intended purpose of the fluid filled teether is to relieve the teething discomfort of infants by giving cool soothing effect when the cool teether is chewed on.

Source page: https://510kreport.com/device/K031094
Methodology: https://510kreport.com/methodology