510(k) · Cleared
ClearedOpaque Herrick Lacrimal Plug
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lacrimedics, Inc. · LZU Plug, Punctum
Cleared on May 9, 2003 after a 100-day review. The FDA summary names no predicate by number. 7 later devices descend from it.
- Decided
- May 9, 2003
- Review
- 100 days
- Class
- Class U
- Product code
- LZU
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK030300 Opaque Herrick Lacrimal PlugLacrimedics, Inc. · 2003
- Descendant · cites it directly · 4 of its ownK140711 Comfortear Lacrisolve Absorbable Punctum Plug, Lacrisolve Absorbable…Paragon Bioteck, Inc. · 2014
- Descendant · 2 generations on · 3 of its ownK150288 PDO Absorbable Punctum PlugRiverpoint Medical · 2015
- Descendant · 3 generations on · 2 of its ownK162361 Soft Plug Extended Duration 180 Canalicular PlugOasis Medical, Inc. · 2017
- Descendant · 4 generations on · 0 of its ownK241229 Hello,eyes® BIO PlugBio Optics Co., Ltd. · 2024
- Descendant · 4 generations on · 0 of its ownK213988 SOFT PLUG Extended Duration 180 Tapered Canalicular PlugOasis Medical, Inc. · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K140711Comfortear Lacrisolve Absorbable Punctum Plug, Lacrisolve Absorbable Punctum Plug…Paragon Bioteck, Inc. · 2014 · cites it directly4descendants
- K150288PDO Absorbable Punctum PlugRiverpoint Medical · 2015 · 2 generations on3descendants
- K162361Soft Plug Extended Duration 180 Canalicular PlugOasis Medical, Inc. · 2017 · 3 generations on2descendants
- K241229Hello,eyes® BIO PlugBio Optics Co., Ltd. · 2024 · 4 generations on0descendants
- K213988SOFT PLUG Extended Duration 180 Tapered Canalicular PlugOasis Medical, Inc. · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030300 | Opaque Herrick Lacrimal Plug | Lacrimedics, Inc. | 2003 | — |
| +1 | K140711 | Comfortear Lacrisolve Absorbable Punctum Plug, Lacrisolve Absorbable Punctum… | Paragon Bioteck, Inc. | 2014 | — |
| +2 | K150288 | PDO Absorbable Punctum Plug | Riverpoint Medical | 2015 | — |
| +3 | K162361 | Soft Plug Extended Duration 180 Canalicular Plug | Oasis Medical, Inc. | 2017 | — |
| +4 | K241229 | Hello,eyes® BIO Plug | Bio Optics Co., Ltd. | 2024 | — |
| +4 | K213988 | SOFT PLUG Extended Duration 180 Tapered Canalicular Plug | Oasis Medical, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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?
The FDA summary names no predicate by number.
What descends from it? (7)
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, K140711 (Paragon Bioteck, Inc., 2014) has gone furthest, with 4 descendants 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 | — |
What is it indicated for?
Dissolvable Opaque Herrick Lacrimal Plugs may be used:
As a diagnostic aid to determine the potential effectiveness of Occlusion Therapy with non-dissolvable plugs.
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 secondary to contact lens use
In the'treatment of Dry Eye Syndrome and the dry eye components of varying Ocular Surface Diseases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030300 · printed Nov 3, 2026
Cite this page
510(k) Report. “K030300: Opaque Herrick Lacrimal Plug.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030300
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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