510(k) · Cleared
ClearedMono-Crawford Naso-Lacrimal Intubation Device
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 Aug 7, 2006 after an 80-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.
- Decided
- Aug 7, 2006
- Review
- 80 days
- Class
- Class U
- Product code
- OKS
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK061404 Mono-Crawford Naso-Lacrimal Intubation DeviceFci Ophthalmics, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK121142 Crawford Biocanaliculus IntubationFci Sas (France Chirurgie Instrumentation) · 2012
- Descendant · cites it directly · 1 of its ownK113316 DCS Lacrimal StentDcs Surgical, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK113536 Masterka 40 Masterka 35 Masterka 30Fci Sas (France Chirurgie Instrumentation) · 2012
- Descendant · 2 generations on · 0 of its ownK201606 LacriJet®Fci (France Chirurgie Instrumentation) Sas · 2020
- Descendant · 2 generations on · 0 of its ownK161373 NunchakuFci (France Chirurgie Instrumentation) · 2016
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K121142Crawford Biocanaliculus IntubationFci Sas (France Chirurgie Instrumentation) · 2012 · cites it directly2descendants
- K113316DCS Lacrimal StentDcs Surgical, Inc. · 2012 · cites it directly1descendant
- K113536Masterka 40 Masterka 35 Masterka 30Fci Sas (France Chirurgie Instrumentation) · 2012 · cites it directly1descendant
- K201606LacriJet®Fci (France Chirurgie Instrumentation) Sas · 2020 · 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) | K061404 | Mono-Crawford Naso-Lacrimal Intubation Device | Fci Ophthalmics, Inc. | 2006 | — |
| +1 | K121142 | Crawford Biocanaliculus Intubation | Fci Sas (France Chirurgie Instrumentation) | 2012 | — |
| +1 | K113316 | DCS Lacrimal Stent | Dcs Surgical, Inc. | 2012 | — |
| +1 | K113536 | Masterka 40 Masterka 35 Masterka 30 | Fci Sas (France Chirurgie Instrumentation) | 2012 | — |
| +2 | K201606 | LacriJet® | Fci (France Chirurgie Instrumentation) Sas | 2020 | — |
| +2 | K161373 | Nunchaku | Fci (France Chirurgie Instrumentation) | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 3 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2020 | 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? (7)
3 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, K121142 (Fci Sas (France Chirurgie Instrumentation), 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?
Indicated in initial surgery in the treatment of monocanalicular lacerations and stenoses requiring intubation.
Further indications are:
Congenital lacrimal duct obstructions
Canalicular lacerations
After treatment of canaliculitis with concretions when curettage of a canaliculus has been performed.
After cacryocystorhinostomy
Epiphora
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K061404 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061404: Mono-Crawford Naso-Lacrimal Intubation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061404
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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