510(k) · Cleared

Cleared

Dacryocath

K113508510(k) TraditionalCleared Aug 31, 2012277-day reviewClass U

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

Armadillo Biomedical, LLC · OKS Lacrimal Stents And Intubation Sets

Cleared on Aug 31, 2012 as substantially equivalent to K935233 (Chiron Vision Corp., 1994) after a 277-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.

Decided: Aug 31, 2012
Review: 277 days
Class: Class U
Product code: OKS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K935233 (1994). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK935233 Iolab Lacrimal Duct CatheterChiron Vision Corp. · 1994
This deviceK113508 DacryocathArmadillo Biomedical, LLC · 2012
Descendant · cites it directly · 0 of its ownK142914 DacryoCATHArmadillo Biomedical, LLC · 2015

Most influential descendants

Showing 1 of 1 · See all

K142914DacryoCATHArmadillo Biomedical, LLC · 2015 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K935233	Iolab Lacrimal Duct Catheter	Chiron Vision Corp.	1994	—
0 (this device)	K113508	Dacryocath	Armadillo Biomedical, LLC	2012	—
+1	K142914	DacryoCATH	Armadillo Biomedical, LLC	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0

FIG. 1 — Lineage of K113508, 1994–2015Source: 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

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K935233	Iolab Lacrimal Duct Catheter Summary page 1 …Lacrimal Stents and Intubation Sets Regulation Pre-Amendment Product Code OKS Predicate K935233 Description The lacrimal duct catheter is a sterile, single use, non-pyrogenic disposable balloon catheter consistin…	Chiron Vision Corp.	1994	—

Also cleared against K935233: 1 other device →

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
K142914	DacryoCATH	Armadillo Biomedical, LLC	2015	0

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, K142914 (Armadillo Biomedical, LLC, 2015) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K935233.

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. 2012, this device’s year, is highlighted.

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 lacrimal duct catheter is indicated for use during dilation of the obstructed nasolacrimal duct in the following populations:

b. The 2mm catheter is indicated for use during dilation of the obstructed nasolacrimal duct obstruction in patients over 12 months of age and under 30 months of age.

b. The 3 mm catheter is indicated for use during dilation of the obstructed nasolacrimal duct in children over 30 months of age.

c. The 5mm catheter is indicated for use in adults during dilation of a lacrimal duct obstruction or blocked dacryocystorhinostomy ostium as a result of the following: functional or complete nasolacrimal duct obstruction, dacryocystitis, or failed dacryocystorhinostomy.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K113508 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113508: Dacryocath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113508

Report an extraction error

Are you the manufacturer?

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