510(k) · Cleared
ClearedSOFT PLUG Extended Duration 180 Tapered 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 Jun 3, 2022 as substantially equivalent to K162361 (Oasis Medical, Inc., 2017) after a 165-day review. Its family tree reaches back 4 generations to 1989.
- Decided
- Jun 3, 2022
- Review
- 165 days
- Class
- Class U
- Product code
- LZU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K890919 (1989). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK890919 Temporary Intracanalicular Collagen ImplantEagle Vision, Inc. · 1989
- 3 generations backK140711 Comfortear Lacrisolve Absorbable Punctum Plug, Lacrisolve Absorbable…Paragon Bioteck, Inc. · 2014
- 2 generations backK150288 PDO Absorbable Punctum PlugRiverpoint Medical · 2015
- 1 generation backK162361 Soft Plug Extended Duration 180 Canalicular PlugOasis Medical, Inc. · 2017
- This deviceK213988 SOFT PLUG Extended Duration 180 Tapered Canalicular PlugOasis Medical, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K890919 | Temporary Intracanalicular Collagen Implant | Eagle Vision, Inc. | 1989 | — |
| −3 | K140711 | Comfortear Lacrisolve Absorbable Punctum Plug, Lacrisolve Absorbable Punctum… | Paragon Bioteck, Inc. | 2014 | — |
| −2 | K150288 | PDO Absorbable Punctum Plug | Riverpoint Medical | 2015 | — |
| −1 | K162361 | Soft Plug Extended Duration 180 Canalicular Plug | Oasis Medical, Inc. | 2017 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K162361 | Soft Plug Extended Duration 180 Canalicular PlugSummary page 4…uct Code: LZU FDA Panel: Ophthalmic Basis for Submission: Traditional 510(k): Device modification Predicate Device: K162361 SOFT PLUG® Extended Duration 180 Canalicular Plug Device Description The Oasis… | 2017 |
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 33 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K162361.
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 SOFT PLUG Extended Duration 180 Canalicular Plugs and the SOFT PLUG Extended Duration 180 Tapered Canalicular Plugs are intended to temporarily block tear flow 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/K213988 · printed Nov 3, 2026
Cite this page
510(k) Report. “K213988: SOFT PLUG Extended Duration 180 Tapered Canalicular Plug.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K213988
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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