510(k) · Cleared
ClearedRitleng Bican.Lacr.Sets/Self Thread. Monokas (CHG.in Ster.)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
G.W.B. Intl., Ltd. · OKS Lacrimal Stents And Intubation Sets
Cleared on Mar 6, 1996 after a 93-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Mar 6, 1996
- Review
- 93 days
- Class
- Class U
- Product code
- OKS
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK955671 Ritleng Bican.Lacr.Sets/Self Thread. Monokas (CHG.in Ster.)G.W.B. Intl., Ltd. · 1996
- Descendant · cites it directly · 2 of its ownK030353 Monocanalicular Stents, Lacrimal Intubation SetsEagle Vision, Inc. · 2003
- Descendant · 2 generations on · 1 of its ownK113316 DCS Lacrimal StentDcs Surgical, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK201892 Ritleng®+ and Ritleng®+ PVPFci (France Chirurgie Instrumentation) Sas · 2021
- Descendant · 3 generations on · 0 of its ownK140290 Stoploss Jones TubeLjt Surgical, Ltd. · 2014
Most influential descendants
Showing 4 of 4 · See all- K030353Monocanalicular Stents, Lacrimal Intubation SetsEagle Vision, Inc. · 2003 · cites it directly2descendants
- K113316DCS Lacrimal StentDcs Surgical, Inc. · 2012 · 2 generations on1descendant
- K201892Ritleng®+ and Ritleng®+ PVPFci (France Chirurgie Instrumentation) Sas · 2021 · cites it directly0descendants
- K140290Stoploss Jones TubeLjt Surgical, Ltd. · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955671 | Ritleng Bican.Lacr.Sets/Self Thread. Monokas (CHG.in Ster.) | G.W.B. Intl., Ltd. | 1996 | — |
| +1 | K030353 | Monocanalicular Stents, Lacrimal Intubation Sets | Eagle Vision, Inc. | 2003 | — |
| +2 | K113316 | DCS Lacrimal Stent | Dcs Surgical, Inc. | 2012 | — |
| +1 | K201892 | Ritleng®+ and Ritleng®+ PVP | Fci (France Chirurgie Instrumentation) Sas | 2021 | — |
| +3 | K140290 | Stoploss Jones Tube | Ljt Surgical, Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
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?
- Of its descendants, K030353 (Eagle Vision, Inc., 2003) 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 | — |
https://510kreport.com/device/K955671 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955671: Ritleng Bican.Lacr.Sets/Self Thread. Monokas (CHG.in Ster.).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955671
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026