510(k) · Cleared
ClearedSelf Retaining Bicanaliculus Intubation Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fci Ophthalmics, Inc. · OKS Lacrimal Stents And Intubation Sets
Cleared on Nov 18, 2004 after a 132-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Nov 18, 2004
- Review
- 132 days
- Class
- Class U
- Product code
- OKS
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK041869 Self Retaining Bicanaliculus Intubation SetFci Ophthalmics, Inc. · 2004
- Descendant · cites it directly · 2 of its ownK120886 LacrifastHiroyasu Higuchi · 2012
- Descendant · cites it directly · 1 of its ownK130375 Self-Retaining Bicanaliculus Intubaton Set IIFci Sas (France Chirurgie Instrumentation) · 2013
- Descendant · 2 generations on · 0 of its ownK170247 Lacriflow CLKaneka Pharma America, LLC · 2017
- Descendant · 2 generations on · 0 of its ownK161373 NunchakuFci (France Chirurgie Instrumentation) · 2016
Most influential descendants
Showing 4 of 4 · See all- K120886LacrifastHiroyasu Higuchi · 2012 · cites it directly2descendants
- K130375Self-Retaining Bicanaliculus Intubaton Set IIFci Sas (France Chirurgie Instrumentation) · 2013 · cites it directly1descendant
- K170247Lacriflow CLKaneka Pharma America, LLC · 2017 · 2 generations on0descendants
- K161373NunchakuFci (France Chirurgie Instrumentation) · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041869 | Self Retaining Bicanaliculus Intubation Set | Fci Ophthalmics, Inc. | 2004 | — |
| +1 | K120886 | Lacrifast | Hiroyasu Higuchi | 2012 | — |
| +1 | K130375 | Self-Retaining Bicanaliculus Intubaton Set II | Fci Sas (France Chirurgie Instrumentation) | 2013 | — |
| +2 | K170247 | Lacriflow CL | Kaneka Pharma America, LLC | 2017 | — |
| +2 | K161373 | Nunchaku | Fci (France Chirurgie Instrumentation) | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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, K120886 (Hiroyasu Higuchi, 2012) 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?
Bicanalicular intubation is indicated in treatments of epiphora
in adults (not to be used in infants), particularly in cases of:
- Meatic pathologies (meatic atresia)
- Canalicular pathologies (canalicular stricture)
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K041869 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041869: Self Retaining Bicanaliculus Intubation Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041869
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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