# K151575: Dynarex Eye Cups

- Pathway: 510(k) (Traditional)
- Applicant: Dynarex Corporation
- Decided: Sep 1, 2015 after 82 days
- Product code: LXQ (Cup, Eye)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K051414 (2005). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140409: Flents Plastic Eye Wash Cup, Apothecary Products, Inc. (2014) Summary page 4.

## Indications for use
The Dynarex Eye Cup is a non-sterile device made of opaque Polyethylene designed to be filled with an eyewash solution and placed over the eye to allow the solution to wash out or flush the affected eye.

Source page: https://510kreport.com/device/K151575
Methodology: https://510kreport.com/methodology