510(k) · Cleared
ClearedTear Pool Dissolvable Punctum Plugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphamed, Inc. · LZU Plug, Punctum
Cleared on Oct 24, 2019 as substantially equivalent to K030300 (Lacrimedics, Inc., 2003) after a 262-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Oct 24, 2019
- Review
- 262 days
- Class
- Class U
- Product code
- LZU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K030300 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK030300 Opaque Herrick Lacrimal PlugLacrimedics, Inc. · 2003
- This deviceK190210 Tear Pool Dissolvable Punctum PlugsAlphamed, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K030300 | Opaque Herrick Lacrimal Plug | Lacrimedics, Inc. | 2003 | — |
| 0 (this device) | K190210 | Tear Pool Dissolvable Punctum Plugs | Alphamed, Inc. | 2019 | — |
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 |
|---|---|---|---|
| * | K030300 | Opaque Herrick Lacrimal PlugSummary page 4…: LZU Predicate Device: Dissolvable Opaque Herrick Lacrimal Plug Predicate Device 510(k) No.: K030300 Description of Device The Tear Pool Dissolvable Punctum Plug is an ophthalmic device commonly referred to as a punctum plug.… | 2003 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K030300.
How does its category compare?
All LZU devicesLZU Plug, Punctum: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Tear Pool Dissolvable Punctum Plugs are designed to provide for temporary occlusion of the tear drainage system.
Punctum Plugs are indicated for:
* As a diagnostic aid to determine the potential effectiveness of long term occlusion
* To temporarily enhance the efficacy of topical medications or ocular lubricants
* After ocular surgery to prevent complications due to dry eyes
* To evaluate treatment of ocular dryness
* To evaluate the dry eye component of ocular surface diseases
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190210 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190210: Tear Pool Dissolvable Punctum Plugs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190210
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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