510(k) · Cleared
ClearedDCS Lacrimal Stent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dcs Surgical, Inc. · OKS Lacrimal Stents And Intubation Sets
Cleared on Nov 8, 2012 as substantially equivalent to K061404 (Fci Ophthalmics, Inc., 2006) and 1 other predicate after a 365-day review. Its family tree reaches back 2 generations to 1988. 1 later device descends from it.
- Decided
- Nov 8, 2012
- Review
- 365 days
- Class
- Class U
- Product code
- OKS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K883233 (1988). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK883233 EV Monocanalicular Stent (TM)Eagle Vision, Inc. · 1988
- 1 generation backK030353 Monocanalicular Stents, Lacrimal Intubation SetsEagle Vision, Inc. · 2003
- This deviceK113316 DCS Lacrimal StentDcs Surgical, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK140290 Stoploss Jones TubeLjt Surgical, Ltd. · 2014
Most influential descendants
Showing 1 of 1 · See all- K140290Stoploss Jones TubeLjt Surgical, Ltd. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K883233 | EV Monocanalicular Stent (TM) | Eagle Vision, Inc. | 1988 | — |
| −1 | K030353 | Monocanalicular Stents, Lacrimal Intubation Sets | Eagle Vision, Inc. | 2003 | — |
| 0 (this device) | K113316 | DCS Lacrimal Stent | Dcs Surgical, Inc. | 2012 | — |
| +1 | 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 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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? (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 | Decided |
|---|---|---|---|
| * | K061404 | Mono-Crawford Naso-Lacrimal Intubation DeviceSummary page 1…Boulder, CO. 80304 Telephone: 303-929-9909 Predicate Devices: Gunther-Weiss Pre-Amendment Jones Tubes FCI Ophthalmics K06 1404 Mono-Crawford Nasolacrimal Intubation Device Eagle Vision, Inc. K03… | 2006 |
| * | K030353 | Monocanalicular Stents, Lacrimal Intubation SetsSummary page 1…Tubes FCI Ophthalmics K06 1404 Mono-Crawford Nasolacrimal Intubation Device Eagle Vision, Inc. K030353 Lacrimal Stents and Intubation Sets Indication for Use: The DCS Lacrimal Stent is intended for use during repair of the… | 2003 |
| * | — | Gunther-Weiss Pre-Amendment Jones Tubes Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140290 | Stoploss Jones Tube | 2014 | 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?
- The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 14.7 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K140290 (Ljt Surgical, Ltd., 2014) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K061404.
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. 2012, this device’s year, is highlighted.
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 DCS Lacrimal Stent is intended for use during repair of the lacrimal system for intubation and bypass to canalicular pathologies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113316 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113316: DCS Lacrimal Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113316
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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