510(k) · Cleared
ClearedNunchaku
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fci (France Chirurgie Instrumentation) · OKS Lacrimal Stents And Intubation Sets
Cleared on Nov 3, 2016 as substantially equivalent to K121142 (Fci Sas (France Chirurgie Instrumentation), 2012) and 2 other predicates after a 170-day review. Its family tree reaches back 2 generations to 1999.
- Decided
- Nov 3, 2016
- Review
- 170 days
- Class
- Class U
- Product code
- OKS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K991238 (1999). 6 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K991238 | Fci Crawford Probe Intubation Sets | Fci Ophthalmics, Inc. | 1999 | — |
| −1 | K121142 | Crawford Biocanaliculus Intubation | Fci Sas (France Chirurgie Instrumentation) | 2012 | — |
| 0 (this device) | K161373 | Nunchaku | Fci (France Chirurgie Instrumentation) | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K121142 | Crawford Biocanaliculus IntubationSummary page 4…edicate Device The Nunchaku is substantially equivalent to the Crawford Bicanaliculus Intubation marketed by FCI Ophthalmics, Inc., 510(k) Premarket Notification Number: K121142, FDA Product Code OKS; and the Nunchaku is also substantially equivalent to the Lacriflow marketed by Kaneka, 510(k) Premarket No… | 2012 |
| * | K120886 | LacrifastSummary page 4…ation Number: K121142, FDA Product Code OKS; and the Nunchaku is also substantially equivalent to the Lacriflow marketed by Kaneka, 510(k) Premarket Notification Number: K120886, FDA Product Code OKS, and to the Self- Retaining Bicanaliculus Intubation Set II marketed by FCI Ophthalmics, Inc., 510(k) Prema… | 2012 |
| * | K130375 | Self-Retaining Bicanaliculus Intubaton Set IISummary page 4…umber: K120886, FDA Product Code OKS, and to the Self- Retaining Bicanaliculus Intubation Set II marketed by FCI Ophthalmics, Inc., 510(k) Premarket Notification Number: K130375, FDA Product Code OKS. K142931/S001 (Nunchaku)… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 13.1 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K121142.
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. 2016, 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 Nunchaku stents are intended for use for nasolacrimal intubation in patients 12 months and older. Indications for nasolacrimal intubation performed with the Nunchaku are:
- Canalicular pathologies (e.g., congenital or acquired stenosis, laceration)
- During dacryocystorhinostomy
- Congenital lacrimal duct obstruction
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161373 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161373: Nunchaku.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161373
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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