510(k) · Cleared
Recalled · Class II · 2022Collagen Implants for the Lacrimal Efficiency Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lacrimedics, Inc. · LZU Plug, Punctum
Cleared on Nov 2, 1989 after a 63-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled once.
- Decided
- Nov 2, 1989
- Review
- 63 days
- Class
- Class U
- Product code
- LZU
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK895342 Collagen Implants for the Lacrimal Efficiency TestLacrimedics, Inc. · 1989
- Descendant · cites it directly · 1 of its ownK013613 Soft Plug Absorbable Plug-SAOasis Medical, Inc. · 2002 · Recalled
- Descendant · cites it directly · 0 of its ownK140026 Collasyn Plug for the Lacrimal Efficiency TestLacrimedics, Inc. · 2014 · Recalled
- Descendant · cites it directly · 0 of its ownK053333 Eaglevision Gellanserts, Model Ref 0040Eagle Vision, Inc. · 2006
Most influential descendants
Showing 3 of 3 · See all- K013613Soft Plug Absorbable Plug-SAOasis Medical, Inc. · 2002 · cites it directly1descendant
- K140026Collasyn Plug for the Lacrimal Efficiency TestLacrimedics, Inc. · 2014 · cites it directly0descendants
- 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) | K895342 | Collagen Implants for the Lacrimal Efficiency Test | Lacrimedics, Inc. | 1989 | — |
| +1 | K013613 | Soft Plug Absorbable Plug-SA | Oasis Medical, Inc. | 2002 | 1 |
| +1 | K140026 | Collasyn Plug for the Lacrimal Efficiency Test | Lacrimedics, Inc. | 2014 | 1 |
| +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 |
| 2006 | 1 | 0 |
| 2014 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 17, 2022 | Class II | Z-0709-2022 | Packaging process control | The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K013613 (Oasis Medical, Inc., 2002) 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/K895342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K895342: Collagen Implants for the Lacrimal Efficiency Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K895342
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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