510(k) · Cleared
ClearedLacriJet®
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fci (France Chirurgie Instrumentation) Sas · OKS Lacrimal Stents And Intubation Sets
Cleared on Dec 18, 2020 as substantially equivalent to K113536 (Fci Sas (France Chirurgie Instrumentation), 2012) and 1 other predicate after a 186-day review. Its family tree reaches back 2 generations to 2006.
- Decided
- Dec 18, 2020
- Review
- 186 days
- Class
- Class U
- Product code
- OKS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K061404 (2006). 3 ancestors in all, the oldest K883233 (1988). 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 | K061404 | Mono-Crawford Naso-Lacrimal Intubation Device | Fci Ophthalmics, Inc. | 2006 | — |
| −1 | K113536 | Masterka 40 Masterka 35 Masterka 30 | Fci Sas (France Chirurgie Instrumentation) | 2012 | — |
| 0 (this device) | K201606 | LacriJet® | Fci (France Chirurgie Instrumentation) Sas | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 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
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 |
|---|---|---|---|
| * | K113536 | Masterka 40 Masterka 35 Masterka 30Summary page 4…ets Product Code: OKS Identification of a Legally Marketed Predicate Device Primary Predicate Device: MASTERKA intubation, 510(k) Premarket Notification Number K113536, FDA Product Code OKS. Secondary Predicate Device: Eagle Vision Monocanalicular Stent, 510(k) Premarket Notification Number K883… | 2012 |
| * | K883233 | EV Monocanalicular Stent (TM)Summary page 4…510(k) Premarket Notification Number K113536, FDA Product Code OKS. Secondary Predicate Device: Eagle Vision Monocanalicular Stent, 510(k) Premarket Notification Number K883233, FDA Product Code OKS. Reference Device: Mini-Monoka, 510(k) Premarket Notification Number K911109, FDA Product Code OKS. === P… | 1988 |
| † | K911109 | Ophta Sil (R), Lachrymal Intubation Sets | 1991 |
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 14 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
- None of the 3 ancestors has a recall.
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. 2020, 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?
LACRIJET® from 30 to 50 mm are indicated in the treatment of congenital lacrimal duct obstructions (stenosis of the valve of Hasner) in patients 12 months and older.
LACRIJET® with small size (15/20 mm) are indicated in the repair of canalicular lacerations.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201606 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201606: LacriJet®.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201606
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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