510(k) · Cleared
ClearedCrawford Biocanaliculus Intubation
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 Aug 9, 2012 as substantially equivalent to K991238 (Fci Ophthalmics, Inc., 1999) and 1 other predicate after a 115-day review. Its family tree reaches back 1 generation to 1999. 2 later devices descend from it.
- Decided
- Aug 9, 2012
- Review
- 115 days
- Class
- Class U
- Product code
- OKS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K991238 (1999). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK991238 Fci Crawford Probe Intubation SetsFci Ophthalmics, Inc. · 1999
- This deviceK121142 Crawford Biocanaliculus IntubationFci Sas (France Chirurgie Instrumentation) · 2012
- Descendant · cites it directly · 0 of its ownK161373 NunchakuFci (France Chirurgie Instrumentation) · 2016
- Descendant · cites it directly · 0 of its ownK160710 Oasis Lacrimal Intubation SetAnodyne · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991238 | Fci Crawford Probe Intubation Sets | Fci Ophthalmics, Inc. | 1999 | — |
| 0 (this device) | K121142 | Crawford Biocanaliculus Intubation | Fci Sas (France Chirurgie Instrumentation) | 2012 | — |
| +1 | K161373 | Nunchaku | Fci (France Chirurgie Instrumentation) | 2016 | — |
| +1 | K160710 | Oasis Lacrimal Intubation Set | Anodyne | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K991238 | Fci Crawford Probe Intubation SetsSummary page 1…awford Bicanaliculus Intubation is substantially equivalent to the Crawford Probe Intubation Set marketed by FCI Ophthalmics, Inc, 51 0(k) Premarket Notification Number: K99 1238, FDA Product Code OKS; and, to-the Mono-Crawford Naso-Lacrimal Intubation Device marketed by FCI Ophthalmics, Inc, 5 10(k) Premar… | 1999 |
| * | K061404 | Mono-Crawford Naso-Lacrimal Intubation DeviceSummary page 1…umber: K99 1238, FDA Product Code OKS; and, to-the Mono-Crawford Naso-Lacrimal Intubation Device marketed by FCI Ophthalmics, Inc, 5 10(k) Premarket Notification Number: K061404, FDA Product Code OKS. General Description The Crawford Bicanaliculus Intubation is a bicanalicular intubation device that cons… | 2006 |
What descends from it? (2)
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?
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 Crawford Bicanaticulus Intubation stents are intended for use for nasolacrimat intubation in patients 12 months of age and older. Indications for nasolacrimal intubation performed with the Crawford Bicanaliculus Intubation are:
Canalicular pathologies (e.g., congenital or acquired stenosis, lacerations)
During dacryocystorhinostomy
Congenital lacrimal duct obstruction
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121142 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121142: Crawford Biocanaliculus Intubation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121142
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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