510(k) · Cleared
ClearedCollagen Intracanalicular Plug
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oasis Medical, Inc. · LZU Plug, Punctum
Cleared on Feb 7, 1995 after a 39-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Feb 7, 1995
- Review
- 39 days
- Class
- Class U
- Product code
- LZU
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK946357 Collagen Intracanalicular PlugOasis Medical, Inc. · 1995
- Descendant · cites it directly · 1 of its ownK040912 Hydrogel Canalicular PlugPartners IN Biomaterials, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK013613 Soft Plug Absorbable Plug-SAOasis Medical, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 0 of its ownK222164 Visant Medical Canalicular PlugVisant Medical, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK053333 Eaglevision Gellanserts, Model Ref 0040Eagle Vision, Inc. · 2006
Most influential descendants
Showing 4 of 4 · See all- K040912Hydrogel Canalicular PlugPartners IN Biomaterials, Inc. · 2004 · cites it directly1descendant
- K013613Soft Plug Absorbable Plug-SAOasis Medical, Inc. · 2002 · cites it directly1descendant
- K222164Visant Medical Canalicular PlugVisant Medical, Inc. · 2022 · 2 generations on0descendants
- K053333Eaglevision Gellanserts, Model Ref 0040Eagle Vision, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K946357 | Collagen Intracanalicular Plug | Oasis Medical, Inc. | 1995 | — |
| +1 | K040912 | Hydrogel Canalicular Plug | Partners IN Biomaterials, Inc. | 2004 | — |
| +1 | K013613 | Soft Plug Absorbable Plug-SA | Oasis Medical, Inc. | 2002 | 1 |
| +2 | K222164 | Visant Medical Canalicular Plug | Visant Medical, Inc. | 2022 | — |
| +1 | K053333 | Eaglevision Gellanserts, Model Ref 0040 | Eagle Vision, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2022 | 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 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K040912 (Partners IN Biomaterials, Inc., 2004) has gone furthest, with 1 descendant 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 | — |
https://510kreport.com/device/K946357 · printed Nov 6, 2026
Cite this page
510(k) Report. “K946357: Collagen Intracanalicular Plug.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K946357
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026