510(k) · Cleared
ClearedEye Irrigator Model #2020
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eye-Deal Ocular Safety Products, Inc. · KYG Device, Irrigation, Ocular Surgery
Cleared on May 15, 1998 as substantially equivalent to K821897 (Mortan, Inc., 1983) after an 87-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- May 15, 1998
- Review
- 87 days
- Class
- Class I
- Product code
- KYG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K821897 (1983). No later device cites it as a predicate yet.
- Root · 1 generation backK821897 LENSMortan, Inc. · 1983
- This deviceK980647 Eye Irrigator Model #2020Eye-Deal Ocular Safety Products, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K821897 | LENS | Mortan, Inc. | 1983 | — |
| 0 (this device) | K980647 | Eye Irrigator Model #2020 | Eye-Deal Ocular Safety Products, Inc. | 1998 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KYG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K821897 | LENSSummary page 1…Immigator, Ocular Irrigator COMMON NAME: Eye irrigator SUBSTANTIALLY EQUIVALENT TO: The Eye Irrigator is substantially equivalent to the Morgan Lens, by Mortan, Inc., K821897 DESCRIPTION of the DEVICE: The Eye-Deal Eye Irrigator, an ocular irrigator, consists of a plastic irrigation tube that works lik… | 1983 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All KYG devicesKYG Device, Irrigation, Ocular Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KYG
FDA has decided no KYG device since 2007.
Median 510(k) review, days · KYG
Too few KYG 510(k)s in any year since 2007 to give a median.
Recalls per year · KYG
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KYG
72in 2025
MAUDE reports naming product code KYG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 4 | 103 |
| 2008 | 0 | — | 0 | 61 |
| 2009 | 0 | — | 0 | 50 |
| 2010 | 0 | — | 2 | 127 |
| 2011 | 0 | — | 0 | 81 |
| 2012 | 0 | — | 0 | 332 |
| 2013 | 0 | — | 0 | 242 |
| 2014 | 0 | — | 0 | 258 |
| 2015 | 0 | — | 0 | 79 |
| 2016 | 0 | — | 0 | 14 |
| 2017 | 0 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 10 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 19 |
| 2022 | 0 | — | 0 | 20 |
| 2023 | 0 | — | 1 | 23 |
| 2024 | 0 | — | 0 | 81 |
| 2025 | 0 | — | 0 | 72 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980647 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980647: Eye Irrigator Model #2020.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980647
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026