510(k) · Cleared
ClearedIolab Lacrimal Duct Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chiron Vision Corp. · OKS Lacrimal Stents And Intubation Sets
Cleared on Sep 15, 1994 after a 318-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Sep 15, 1994
- Review
- 318 days
- Class
- Class U
- Product code
- OKS
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK935233 Iolab Lacrimal Duct CatheterChiron Vision Corp. · 1994
- Descendant · cites it directly · 1 of its ownK113867 Lacricath Lacrimal Duct CatheterQuest Medical, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK113508 DacryocathArmadillo Biomedical, LLC · 2012
- Descendant · 2 generations on · 0 of its ownK142914 DacryoCATHArmadillo Biomedical, LLC · 2015
- Descendant · 2 generations on · 0 of its ownK123831 Ophtacath KitFrance Chirurgae Instrumentation · 2013
Most influential descendants
Showing 4 of 4 · See all- K113867Lacricath Lacrimal Duct CatheterQuest Medical, Inc. · 2012 · cites it directly1descendant
- K113508DacryocathArmadillo Biomedical, LLC · 2012 · cites it directly1descendant
- K142914DacryoCATHArmadillo Biomedical, LLC · 2015 · 2 generations on0descendants
- K123831Ophtacath KitFrance Chirurgae Instrumentation · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K935233 | Iolab Lacrimal Duct Catheter | Chiron Vision Corp. | 1994 | — |
| +1 | K113867 | Lacricath Lacrimal Duct Catheter | Quest Medical, Inc. | 2012 | — |
| +1 | K113508 | Dacryocath | Armadillo Biomedical, LLC | 2012 | — |
| +2 | K142914 | DacryoCATH | Armadillo Biomedical, LLC | 2015 | — |
| +2 | K123831 | Ophtacath Kit | France Chirurgae Instrumentation | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 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 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
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | — | Lacrimal Probe Named without a submission number | |
| * | — | Lacrimal Dilator Named without a submission number |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K113867 (Quest Medical, Inc., 2012) has gone furthest, with 1 descendant of its own.
How does its category compare?
All OKS devicesOKS Lacrimal Stents And Intubation Sets: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OKS
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · OKS
277in 2012
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 7 | 277 | 0 | 3 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 1 | — | 0 | 8 |
| 2015 | 1 | — | 0 | 14 |
| 2016 | 2 | — | 0 | 21 |
| 2017 | 1 | — | 0 | 18 |
| 2018 | 0 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 8 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 1 | — | 0 | 6 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The new device and the predicate devices are intended for single-use during dilatation of an obstructed nasolacrimal duct system to correct epiphora.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K935233 · printed Nov 6, 2026
Cite this page
510(k) Report. “K935233: Iolab Lacrimal Duct Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935233
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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