510(k) · Cleared
ClearedVisant Medical Canalicular Plug
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Visant Medical, Inc. · LZU Plug, Punctum
Cleared on Dec 23, 2022 as substantially equivalent to K040912 (Partners IN Biomaterials, Inc., 2004) after a 155-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Dec 23, 2022
- Review
- 155 days
- Class
- Class U
- Product code
- LZU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K946357 (1995). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K946357 | Collagen Intracanalicular Plug | Oasis Medical, Inc. | 1995 | — |
| −1 | K040912 | Hydrogel Canalicular Plug | Partners IN Biomaterials, Inc. | 2004 | — |
| 0 (this device) | K222164 | Visant Medical Canalicular Plug | Visant Medical, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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
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 |
|---|---|---|---|
| * | K040912 | Hydrogel Canalicular PlugSummary page 4…ified PRODUCT CODE LZU III. PREDICATE DEVICE PREDICATE DEVICE: Oasis Form Fit K040912 Partners in Biomaterials, Inc. IV. DEVICE DESCRIPTION The Visant Medical Canalicular Pl… | 2004 |
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?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 18.1 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All LZU devicesLZU Plug, Punctum: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
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?
The Visant Medical Canalicular Plug is intended to block tear drainage by occlusion of the canalicular system. It is indicated for use, for up to 6 months, in patients experiencing dry eye symptoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222164 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222164: Visant Medical Canalicular Plug.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222164
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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