510(k) · Cleared
ClearedHydrogel Canalicular Plug
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Partners IN Biomaterials, Inc. · LZU Plug, Punctum
Cleared on Nov 16, 2004 as substantially equivalent to K022043 (Medennium, Inc., 2002) and 1 other predicate after a 222-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Nov 16, 2004
- Review
- 222 days
- Class
- Class U
- Product code
- LZU
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K946357 (1995). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K222164Visant Medical Canalicular PlugVisant Medical, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K946357 | Collagen Intracanalicular Plug | Oasis Medical, Inc. | 1995 | — |
| 0 (this device) | K040912 | Hydrogel Canalicular Plug | Partners IN Biomaterials, Inc. | 2004 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (2)
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 |
|---|---|---|---|
| * | K022043 | Smart Plug, Model 500; Smartplug Forceps, Model 502; Push Rod, Model 503Summary page 4…The proposed device, the Hydrogel Canalicular Plug, claims substantial equivalence in intended use and method of operation to the Medennium Smart Plug (K022043). Both plugs are a one-size-fits-all design that change shape upon insertion in to the canaliculus in order to… | 2002 |
| * | K946357 | Collagen Intracanalicular PlugSummary page 4…prior to insertion into the canaliculus. The Hydrogel Canalicular Plug also claims substantial equivalence to collagen plugs marketed by Oasis Medical (K946357), and others, in both size and function. Both of these plugs are approximately 0.3mm diameter by 2.5mm long. W… | 1995 |
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 |
|---|---|---|---|
| K222164 | Visant Medical Canalicular Plug | 2022 | 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?
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?
The Hydrogel Canalicular Plug is intended for use in patients experiencing dry eye symptoms such as redness, burning, reflex tearing, itching, or foreign body sensations, which can be relieved by blocking of the punctum.
The Hydrogel Canalicular Plug may be used in the treatment of dry eye syndrome and the dry eye component of various ocular surface diseases.
When indicated, the Hydrogel Canalicular Plug may be used after surgery of the eye to prevent complications due to dry eye and to enhance the retention of ocular medications on the eye. Patients experiencing dry eye related contact lens problems may also be aided by the Hydrogel Canalicular Plug.
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/K040912 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040912: Hydrogel 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/K040912
Report an extraction error
Are you the manufacturer?
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