510(k) · Cleared
ClearedSelf-Retaining Bicanaliculus Intubaton Set II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fci Sas (France Chirurgie Instrumentation) · OKS Lacrimal Stents And Intubation Sets
Cleared on Dec 4, 2013 as substantially equivalent to K041869 (Fci Ophthalmics, Inc., 2004) after a 293-day review. Its family tree reaches back 1 generation to 2004. 1 later device descends from it.
- Decided
- Dec 4, 2013
- Review
- 293 days
- Class
- Class U
- Product code
- OKS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K041869 (2004). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK041869 Self Retaining Bicanaliculus Intubation SetFci Ophthalmics, Inc. · 2004
- This deviceK130375 Self-Retaining Bicanaliculus Intubaton Set IIFci Sas (France Chirurgie Instrumentation) · 2013
- Descendant · cites it directly · 0 of its ownK161373 NunchakuFci (France Chirurgie Instrumentation) · 2016
Most influential descendants
Showing 1 of 1 · See all- K161373NunchakuFci (France Chirurgie Instrumentation) · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K041869 | Self Retaining Bicanaliculus Intubation Set | Fci Ophthalmics, Inc. | 2004 | — |
| 0 (this device) | K130375 | Self-Retaining Bicanaliculus Intubaton Set II | Fci Sas (France Chirurgie Instrumentation) | 2013 | — |
| +1 | K161373 | Nunchaku | Fci (France Chirurgie Instrumentation) | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (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 | Decided |
|---|---|---|---|
| * | K041869 | Self Retaining Bicanaliculus Intubation SetSummary page 1…tubation Set 11 is substantially equivalent to the Self- Retaining Bicanaliculus Intubation Set marketed by FCI Ophthalmics, Inc., 5 10(k) Premarket Notification Number: K04 1869, FDA Product Code OKS. General Description The Self-Retaining Bicanaliculus Intubation Set Illis a bicanalicular intubation devi… | 2004 |
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 |
|---|---|---|---|
| K161373 | Nunchaku | 2016 | 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?
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. 2013, 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?
Bicanalicular intubation is indicated in treatments of epiphora in adults. Indications for bicanalicular intubation performed with the Self-Retaining Bicanaliculus Stent 11 are:
* Punctal stenosis
* Canalicular stenosis within the lacrimal drainage system
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130375 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130375: Self-Retaining Bicanaliculus Intubaton Set II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130375
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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