510(k) · Cleared
ClearedSoft Plug Extended Duration 180 Canalicular Plug
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oasis Medical, Inc. · LZU Plug, Punctum
Cleared on Apr 17, 2017 as substantially equivalent to K150288 (Riverpoint Medical, 2015) after a 237-day review. Its family tree reaches back 3 generations to 1989. 2 later devices descend from it.
- Decided
- Apr 17, 2017
- Review
- 237 days
- Class
- Class U
- Product code
- LZU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K890919 (1989). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK890919 Temporary Intracanalicular Collagen ImplantEagle Vision, Inc. · 1989
- 2 generations backK140711 Comfortear Lacrisolve Absorbable Punctum Plug, Lacrisolve Absorbable…Paragon Bioteck, Inc. · 2014
- 1 generation backK150288 PDO Absorbable Punctum PlugRiverpoint Medical · 2015
- This deviceK162361 Soft Plug Extended Duration 180 Canalicular PlugOasis Medical, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK241229 Hello,eyes® BIO PlugBio Optics Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK213988 SOFT PLUG Extended Duration 180 Tapered Canalicular PlugOasis Medical, Inc. · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K890919 | Temporary Intracanalicular Collagen Implant | Eagle Vision, Inc. | 1989 | — |
| −2 | K140711 | Comfortear Lacrisolve Absorbable Punctum Plug, Lacrisolve Absorbable Punctum… | Paragon Bioteck, Inc. | 2014 | — |
| −1 | K150288 | PDO Absorbable Punctum Plug | Riverpoint Medical | 2015 | — |
| 0 (this device) | K162361 | Soft Plug Extended Duration 180 Canalicular Plug | Oasis Medical, Inc. | 2017 | — |
| +1 | K241229 | Hello,eyes® BIO Plug | Bio Optics Co., Ltd. | 2024 | — |
| +1 | K213988 | SOFT PLUG Extended Duration 180 Tapered Canalicular Plug | Oasis Medical, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K150288 | PDO Absorbable Punctum PlugSummary page 4…Regulatory Class: Unclassified Product Code: LZU FDA Panel: Ophthalmic Predicate Device: K150288 – PDO Absorbable Punctal Plug Device Description The OASIS Medical SOFT PLUG® Extended Duration… | 2015 |
What descends from it? (2)
2 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?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K241229 (Bio Optics Co., Ltd., 2024) has gone furthest, with 0 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. 2017, 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 Soft Plug® Extended Duration 180 Canalicular Plugs are intended to temporarily block tear drainage by the occlusion
of the canaliculus in order to:
- Temporarily treat dry eye syndrome, and the dry eye components of various ocular surface diseases,
- Temporarily enhance the efficacy of topical medications or ocular lubricants,
- Temporarily treat contact lens intolerance secondary to dry eye,
- Temporarily treat dry eye after ocular surgery, and
- Determine the potential effectiveness of permanent occlusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162361 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162361: Soft Plug Extended Duration 180 Canalicular Plug.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162361
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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