# K020296: Adult Silicone Ear Plugs, Models # 68053, 68057

- Pathway: 510(k) (Traditional)
- Applicant: Apothecary Products, Inc.
- Decided: Jun 25, 2002 after 148 days
- Product code: EWD (Protector, Hearing (Insert))
- Device class: U
- 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
Adult Silicone Ear Plugs are used for protection from noise. This device is for adult use only.

Source page: https://510kreport.com/device/K020296
Methodology: https://510kreport.com/methodology