510(k) · Cleared

Recalled · 2006

Soft Plug Absorbable Plug-SA

K013613510(k) TraditionalCleared Jun 27, 2002234-day reviewClass URecalls 1

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

Cleared on Jun 27, 2002 as substantially equivalent to K946357 (Oasis Medical, Inc., 1995) and 3 other predicates after a 234-day review. Its family tree reaches back 1 generation to 1989. 1 later device descends from it. It has been recalled once.

Decided: Jun 27, 2002
Review: 234 days
Class: Class U
Product code: LZU
Recalls: 1
Predicates: 4

Its longest line of descent runs back 1 generation to K890919 (1989). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK890919 Temporary Intracanalicular Collagen ImplantEagle Vision, Inc. · 1989
This deviceK013613 Soft Plug Absorbable Plug-SAOasis Medical, Inc. · 2002
Descendant · cites it directly · 0 of its ownK053333 Eaglevision Gellanserts, Model Ref 0040Eagle Vision, Inc. · 2006

Most influential descendants

Showing 1 of 1 · See all

K053333Eaglevision Gellanserts, Model Ref 0040Eagle Vision, Inc. · 2006 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K890919	Temporary Intracanalicular Collagen Implant	Eagle Vision, Inc.	1989	—
0 (this device)	K013613	Soft Plug Absorbable Plug-SA	Oasis Medical, Inc.	2002	—
+1	K053333	Eaglevision Gellanserts, Model Ref 0040	Eagle Vision, Inc.	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1990	1	0
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0

FIG. 1 — Lineage of K013613, 1989–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (4)

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	Applicant	Decided	Recalls
*	K946357	Collagen Intracanalicular Plug Summary page 1 …eration to t h e various colla en intracanalicular plugs in the market today. These include the Soft 8 Plug Colfagen lntracanalicular Plug by OASIS Medical (K946357),the Temporary lntracanalicular Plug by Eagle Vision (K890919), and the Collagen implants For Use in the Lacrimal Efficiency…	Oasis Medical, Inc.	1995	—
*	K890919	Temporary Intracanalicular Collagen Implant Summary page 1 …e market today. These include the Soft 8 Plug Colfagen lntracanalicular Plug by OASIS Medical (K946357),the Temporary lntracanalicular Plug by Eagle Vision (K890919), and the Collagen implants For Use in the Lacrimal Efficiency TestTM by Lacrimedics (K895342). All of these plugs are 2 mrn…	Eagle Vision, Inc.	1989	—
*	K895342	Collagen Implants for the Lacrimal Efficiency Test Summary page 1 …edical (K946357),the Temporary lntracanalicular Plug by Eagle Vision (K890919), and the Collagen implants For Use in the Lacrimal Efficiency TestTM by Lacrimedics (K895342). All of these plugs are 2 mrn long and are cut from nan-sterile suture material. The implants are intended to be inserted into…	Lacrimedics, Inc.	1989	1
*	K896175	Herrick Lacrimal Plug TM. Summary page 1 …several days. The proposed device. the Soft Plug@Absorbable Plugs - SA, is also similar in intended use and operation to the Herrick Lam-mal Plugm by Lacrimedics (K896175). This is a silicone intracanalicular plug intended for inseftion into the canaliculus to permanently block fluid fiow. It ap…	Lacrimedics, Inc.	1990	—

Also cleared against K946357: 2 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K053333	Eaglevision Gellanserts, Model Ref 0040	Eagle Vision, Inc.	2006	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jul 6, 2006	Not classified	Z-1520-06	Package design/selection	Labeled with an incorrect diameter

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 4 ancestors has a recall of any class.
Of its descendants, K053333 (Eagle Vision, Inc., 2006) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K946357.

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

2007high 3 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZU

148in 2014

2007high 148 (2014)2026

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

Recalls per year · LZU

2in 2022

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

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

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 OASIS Medical Soft Plug@ Absorbable Plug - SA is intended for temporary 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 tbe canaliculus. It may be used in the treatment of dry eye syndrome and the dry eye components of various ocular surface diseases. When indicated, the OASIS Medical Soft Plug@ Absorbable Plug - SA may be used after surgery of the eye to prevent complications due to dry eye and to enhance the retention of ocular medications on the eye.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K013613 · printed Nov 5, 2026

Cite this page

510(k) Report. “K013613: Soft Plug Absorbable Plug-SA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013613

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026