# K980647: Eye Irrigator Model #2020

- Pathway: 510(k) (Traditional)
- Applicant: Eye-Deal Ocular Safety Products, Inc.
- Decided: May 15, 1998 after 87 days
- Product code: KYG (Device, Irrigation, Ocular Surgery)
- Device class: 1
- Regulation: 21 CFR 886.4360
- 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 K821897 (1983). 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)
- K821897: LENS, Mortan, Inc. (1983) Summary page 1.

## Indications for use
The Eye Irrigator, Ocular Irrigating System, is indicated for use as an eye-irrigating device. It is designed especially for post-traumatic injury, chemical exposure and burns, permitting irrigation of the eye and under the upper eyelid, with sterile saline.

Source page: https://510kreport.com/device/K980647
Methodology: https://510kreport.com/methodology