510(k) · Cleared
ClearedLENS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mortan, Inc. · KYG Device, Irrigation, Ocular Surgery
Cleared on Jan 5, 1983 after a 191-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.
- Decided
- Jan 5, 1983
- Review
- 191 days
- Class
- Class I
- Product code
- KYG
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK821897 LENSMortan, Inc. · 1983
- Descendant · cites it directly · 0 of its ownK980647 Eye Irrigator Model #2020Eye-Deal Ocular Safety Products, Inc. · 1998
Most influential descendants
Showing 1 of 1 · See all- K980647Eye Irrigator Model #2020Eye-Deal Ocular Safety Products, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K821897 | LENS | Mortan, Inc. | 1983 | — |
| +1 | K980647 | Eye Irrigator Model #2020 | Eye-Deal Ocular Safety Products, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980647 | Eye Irrigator Model #2020 | 1998 | 0 |
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?
- Of its descendants, K980647 (Eye-Deal Ocular Safety Products, Inc., 1998) has gone furthest, with 0 descendants of its own.
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 | — |
https://510kreport.com/device/K821897 · printed Nov 4, 2026
Cite this page
510(k) Report. “K821897: LENS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K821897
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026