510(k) · Cleared
ClearedRitleng®+ and Ritleng®+ PVP
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 Mar 11, 2021 as substantially equivalent to K955671 (G.W.B. Intl., Ltd., 1996) after a 246-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Mar 11, 2021
- Review
- 246 days
- Class
- Class U
- Product code
- OKS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955671 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK955671 Ritleng Bican.Lacr.Sets/Self Thread. Monokas (CHG.in Ster.)G.W.B. Intl., Ltd. · 1996
- This deviceK201892 Ritleng®+ and Ritleng®+ PVPFci (France Chirurgie Instrumentation) Sas · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955671 | Ritleng Bican.Lacr.Sets/Self Thread. Monokas (CHG.in Ster.) | G.W.B. Intl., Ltd. | 1996 | — |
| 0 (this device) | K201892 | Ritleng®+ and Ritleng®+ PVP | Fci (France Chirurgie Instrumentation) Sas | 2021 | — |
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 K201606 LacriJet®score 0.8 · 2 generations · no Class I recall
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K955671 | Ritleng Bican.Lacr.Sets/Self Thread. Monokas (CHG.in Ster.)Summary page 4…gally Marketed Predicate Device RITLENG®+ is substantially equivalent to the RITLENG® intubation marketed by FCI Ophthalmics, Inc., 510(k) Premarket Notification Number K955671, FDA Product Code OKS. General Description The RITLENG®+ is a self-retaining nasal bicanalicular intubation for the lacrimal du… | 1996 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K955671.
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. 2021, 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 RITLENG®+ products are indicated in the treatment of epiphora in patients of 12 months and older in cases of:
- Canalicular pathologies (stenoses, obstructions, lacerations),
- Congenital duct obstruction (Hasner valve stenosis),
- Dacryocystorhinostomy (conventional or laser).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201892 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201892: Ritleng®+ and Ritleng®+ PVP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201892
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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