510(k) · Cleared
ClearedLacrimal Intubation Set, Dacryocystorhinostomy (DCR) Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hurricane Medical · OKS Lacrimal Stents And Intubation Sets
Cleared on May 18, 1999 after a 77-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- May 18, 1999
- Review
- 77 days
- Class
- Class U
- Product code
- OKS
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK990672 Lacrimal Intubation Set, Dacryocystorhinostomy (DCR) SetHurricane Medical · 1999
- Descendant · cites it directly · 2 of its ownK030353 Monocanalicular Stents, Lacrimal Intubation SetsEagle Vision, Inc. · 2003
- Descendant · 2 generations on · 1 of its ownK113316 DCS Lacrimal StentDcs Surgical, Inc. · 2012
- Descendant · 3 generations on · 0 of its ownK140290 Stoploss Jones TubeLjt Surgical, Ltd. · 2014
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990672 | Lacrimal Intubation Set, Dacryocystorhinostomy (DCR) Set | Hurricane Medical | 1999 | — |
| +1 | K030353 | Monocanalicular Stents, Lacrimal Intubation Sets | Eagle Vision, Inc. | 2003 | — |
| +2 | K113316 | DCS Lacrimal Stent | Dcs Surgical, Inc. | 2012 | — |
| +3 | K140290 | Stoploss Jones Tube | Ljt Surgical, Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2012 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | — | Lacrimal Intubation Set manufactured and distributed by JEDMED Named without a submission number | |
| * | — | Canaliculus Intubation Set manufactured and distributed by SOLAN Named without a submission number | |
| * | — | Lacrimal Intubation Set and DCR Set manufactured and distributed by VISITEC Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030353 | Monocanalicular Stents, Lacrimal Intubation Sets | 2003 | 2 |
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, K030353 (Eagle Vision, Inc., 2003) has gone furthest, with 2 descendants 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?
These devices are used in ophthalmic surgery to reconstruct the lacrimal outflow system,
dacryocystorhinostomy, and other lacrimal system reconstruction.
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/K990672 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990672: Lacrimal Intubation Set, Dacryocystorhinostomy (DCR) Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990672
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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