510(k) Report

510(k) · Cleared

Cleared

Silicone Punctal Plug

K980437510(k) TraditionalCleared Apr 30, 199885-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Oasis Medical, Inc. · LZU Plug, Punctum

Cleared on Apr 30, 1998 as substantially equivalent to K945906 (Oasis Medical, Inc., 1995) after an 85-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.

Decided
Apr 30, 1998
Review
85 days
Class
Class U
Product code
LZU
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K945906 (1995). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant clearedK945906 · Silicone Punctal Plug · Oasis Medical, Inc. · 19951995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant K945906 · Silicone Punctal Plug · Oasis Medical, Inc. · 19950
  1. Root · 1 generation backK945906 Silicone Punctal PlugOasis Medical, Inc. · 1995
  2. This deviceK980437 Silicone Punctal PlugOasis Medical, Inc. · 1998
  3. Descendant · cites it directly · 0 of its ownK040231 Inteliport Occluding DeviceAlcon, Inc. · 2004

Most influential descendants

Showing 1 of 1 · See all
  • K040231Inteliport Occluding DeviceAlcon, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K945906Silicone Punctal PlugOasis Medical, Inc.1995—
0 (this device)K980437Silicone Punctal PlugOasis Medical, Inc.1998—
+1K040231Inteliport Occluding DeviceAlcon, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
FIG. 1 — Lineage of K980437, 1995–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K241229 Hello,eyes® BIO Plugscore 8.5 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K945906Silicone Punctal Plug
Summary page 2
….9 mm 1.4 mm 2.0 mm Substantial Equivalence Comparison: The OASIS Medical Silicone Punctal Plug is substantially equivalent to the OASIS Medical Silicone Punctal Plug (K945906). The OASIS Medical Silicone Punctal Plug is identical to the predicate device except for its physical design and a modifieed ins…
Oasis Medical, Inc.1995—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K040231Inteliport Occluding DeviceAlcon, Inc.20040

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.
  • Of its descendants, K040231 (Alcon, Inc., 2004) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LZU devices

LZU Plug, Punctum: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LZU

1in 2024

2009: 12014: 32015: 12016: 12017: 12019: 12022: 22024: 1
2007high 3 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZU

148in 2014

2014: 148 days median
2007high 148 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LZU

2in 2022

2022: 2
2007high 2 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LZU

3in 2025

2007: 102008: 122009: 112010: 52011: 62012: 72013: 172014: 102015: 12017: 32018: 22020: 22023: 52024: 12025: 3
2007high 17 (2013) · low 0 (2016)2025

MAUDE reports naming product code LZU, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—010
20080—012
20091—011
20100—05
20110—06
20120—07
20130—017
20143148010
20151—01
20161—00
20171—03
20180—02
20191—00
20200—02
20210—00
20222—20
20230—05
20241—01
20250—03
20260—0—

What is it indicated for?

The OASIS® Medical Silicone Punctal 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 blockage of the punctum Silicone Punctal Plug may be used in the treatment of dry eye syndrome and the dry eye components of various ocular surface diseases such as corneal ulcers, conjunctivitis, pyterygium, blepharitis, keratitis, red lid margins…

Read the full statement (155 words)

The OASIS® Medical Silicone Punctal 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 blockage of the punctum

Silicone Punctal Plug may be used in the treatment of dry eye syndrome and the dry eye components of various ocular surface diseases such as corneal ulcers, conjunctivitis, pyterygium, blepharitis, keratitis, red lid margins, recurrent chalazions, recurrent corneal erosion, filamentry keratitis and other external eye diseases.

Other patients that may benefit are: cataract patients, patients with arthritis, patients medicated for hypertension, contact wearers of any age, seasonal allergy sufferers, patients who live in dry climates, or spend extended periods in air conditioning, and any others who suffer from dry eye irritation. It is also reasonable that eye drops of many kinds would be more effective if retained on the surface of the eye, rather than drained into the sinus.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Oasis Medical, Inc.

17 FDA decisions under this applicant name. See the company

  • K213988SOFT PLUG Extended Duration 180 Tapered Canalicular PlugOasis Medical, Inc. · 2022
  • K162361Soft Plug Extended Duration 180 Canalicular PlugOasis Medical, Inc. · 2017
  • K032297Disposable N-PE Mickrokeratome BladesOasis Medical, Inc. · 2003
  • K030401Disposable M2-PE Microkeratome BladesOasis Medical, Inc. · 2003
  • K022205Disposable N-PE Microkeratome BladesOasis Medical, Inc. · 2002

Recent decisions in LZU

The LZU category page

  • K241229Hello,eyes® BIO PlugBio Optics Co., Ltd. · 2024
  • K222164Visant Medical Canalicular PlugVisant Medical, Inc. · 2022
  • K213988SOFT PLUG Extended Duration 180 Tapered Canalicular PlugOasis Medical, Inc. · 2022
  • K190210Tear Pool Dissolvable Punctum PlugsAlphamed, Inc. · 2019
  • K162361Soft Plug Extended Duration 180 Canalicular PlugOasis Medical, Inc. · 2017

https://510kreport.com/device/K980437 · printed Nov 6, 2026

Cite this page

510(k) Report. “K980437: Silicone Punctal Plug.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980437

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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