510(k) · Cleared

Cleared

Monocanalicular Stents, Lacrimal Intubation Sets

K030353510(k) TraditionalCleared Apr 25, 200381-day reviewClass U

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

Eagle Vision, Inc. · OKS Lacrimal Stents And Intubation Sets

Cleared on Apr 25, 2003 as substantially equivalent to K883233 (Eagle Vision, Inc., 1988) and 2 other predicates after an 81-day review. Its family tree reaches back 1 generation to 1988. 2 later devices descend from it.

Decided: Apr 25, 2003
Review: 81 days
Class: Class U
Product code: OKS
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K883233 (1988). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK883233 EV Monocanalicular Stent (TM)Eagle Vision, Inc. · 1988
This deviceK030353 Monocanalicular Stents, Lacrimal Intubation SetsEagle Vision, Inc. · 2003
Descendant · cites it directly · 1 of its ownK113316 DCS Lacrimal StentDcs Surgical, Inc. · 2012
Descendant · 2 generations on · 0 of its ownK140290 Stoploss Jones TubeLjt Surgical, Ltd. · 2014

Most influential descendants

Showing 2 of 2 · See all

K113316DCS Lacrimal StentDcs Surgical, Inc. · 2012 · cites it directly1descendant
K140290Stoploss Jones TubeLjt Surgical, Ltd. · 2014 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K883233	EV Monocanalicular Stent (TM)	Eagle Vision, Inc.	1988	—
0 (this device)	K030353	Monocanalicular Stents, Lacrimal Intubation Sets	Eagle Vision, Inc.	2003	—
+1	K113316	DCS Lacrimal Stent	Dcs Surgical, Inc.	2012	—
+2	K140290	Stoploss Jones Tube	Ljt Surgical, Ltd.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1999	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2014	1	0

FIG. 1 — Lineage of K030353, 1988–2014Source: 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 OKS? 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 OKS device

#1 K201892 Ritleng®+ and Ritleng®+ PVPscore 1.0 · 1 generation · no Class I recall
#2 Held for the reportin the report

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What was it cleared against? (3)

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
*	K883233	EV Monocanalicular Stent (TM) Summary page 1 …: Probe, lacrimal DEVICE CLASSIFICATION: Class II per 21 CFR Q 886.4350 PRODUCT CODE 86 (HNL) PREDICATE DEVICE: EVTMMonocanalicular Stent (cleared under K883233), the Lacrimal Intubation Set & DCR Set (cleared under K990672), and the Ritleng Bicana…	Eagle Vision, Inc.	1988	—
*	K990672	Lacrimal Intubation Set, Dacryocystorhinostomy (DCR) Set Summary page 1 …DUCT CODE 86 (HNL) PREDICATE DEVICE: EVTMMonocanalicular Stent (cleared under K883233), the Lacrimal Intubation Set & DCR Set (cleared under K990672), and the Ritleng Bicanaliculus Intubation Set (cleared under K955671) SUBSTANTIALLY EQUIVALENT To: The…	Hurricane Medical	1999	—
*	K955671	Ritleng Bican.Lacr.Sets/Self Thread. Monokas (CHG.in Ster.) Summary page 1 …33), the Lacrimal Intubation Set & DCR Set (cleared under K990672), and the Ritleng Bicanaliculus Intubation Set (cleared under K955671) SUBSTANTIALLY EQUIVALENT To: The MonoStentTMMonocanalicular Stent, the Eaglevision0 Lacrimal Intubation Set, and the Eaglev…	G.W.B. Intl., Ltd.	1996	—

Also cleared against K883233: 1 other device →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K113316	DCS Lacrimal Stent	Dcs Surgical, Inc.	2012	1

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?

None of the 3 ancestors has a recall.
Of its descendants, K113316 (Dcs Surgical, Inc., 2012) has gone furthest, with 1 descendant of its own.
1 other device also cites its predicate K883233.

How does its category compare?

All OKS devices

OKS Lacrimal Stents And Intubation Sets: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OKS

1in 2021

2007high 7 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OKS

277in 2012

2007high 277 (2012)2026

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

Recalls per year · OKS

No recall names OKS since 2007.

Adverse event reports per year · OKS

3in 2022

2007high 21 (2016) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	2
2012	7	277	3
2013	2	—	3
2014	1	—	8
2015	1	—	14
2016	2	—	21
2017	1	—	18
2018	0	—	6
2019	0	—	8
2020	1	—	2
2021	1	—	6
2022	0	—	3
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The MonoStentTMMonocanalicular Stent, the EagleVisionB Lacrimal Intubation Set, and the EagleVisionB K Type Lacrimal Intubation Set are lacrimal stents and their delivery systems. They are intended for use in lacrimal system reconstruction. This includes, but is not limited to, treatment of: epiphora in infants or adults; canalicular pathologies such as stenosis; obstruction or laceration; and conditions requiring dacryocystorhinostomy (conventional OT laser); or imperforation of the nasolacrimal duct in an infant.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030353 · printed Nov 3, 2026

Cite this page

510(k) Report. “K030353: Monocanalicular Stents, Lacrimal Intubation Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030353

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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