510(k) · Cleared
ClearedPunctual Occluder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Odyssey Medical, Inc. · LZU Plug, Punctum
Cleared on Apr 23, 1997 after a 63-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Apr 23, 1997
- Review
- 63 days
- Class
- Class U
- Product code
- LZU
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK970631 Punctual OccluderOdyssey Medical, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK090938 Flow ControllerOdyssey Medical, Inc. · 2009
Most influential descendants
Showing 1 of 1 · See all- K090938Flow ControllerOdyssey Medical, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970631 | Punctual Occluder | Odyssey Medical, Inc. | 1997 | — |
| +1 | K090938 | Flow Controller | Odyssey Medical, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
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 LZU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LZU device
- #1 K241229 Hello,eyes® BIO Plugscore 8.5 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | — | EV - Freeman Punctum Plug Named without a submission number |
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 |
|---|---|---|---|
| K090938 | Flow Controller | 2009 | 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, K090938 (Odyssey Medical, Inc., 2009) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LZU devicesLZU Plug, Punctum: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LZU
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LZU
148in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZU
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZU
3in 2025
MAUDE reports naming product code LZU, 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 | — | 0 | 10 |
| 2008 | 0 | — | 0 | 12 |
| 2009 | 1 | — | 0 | 11 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 17 |
| 2014 | 3 | 148 | 0 | 10 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 2 | 0 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Punctal Occluders are intended for the treatment of “dry eye” conditions through the total occlusion of individual punctal openings.
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/K970631 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970631: Punctual Occluder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970631
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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