510(k) · Cleared
ClearedMasterka 40 Masterka 35 Masterka 30
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 3, 2012 as substantially equivalent to K061404 (Fci Ophthalmics, Inc., 2006) after a 247-day review. Its family tree reaches back 1 generation to 2006. 1 later device descends from it.
- Decided
- Aug 3, 2012
- Review
- 247 days
- Class
- Class U
- Product code
- OKS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K061404 (2006). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK061404 Mono-Crawford Naso-Lacrimal Intubation DeviceFci Ophthalmics, Inc. · 2006
- This deviceK113536 Masterka 40 Masterka 35 Masterka 30Fci Sas (France Chirurgie Instrumentation) · 2012
- Descendant · cites it directly · 0 of its ownK201606 LacriJet®Fci (France Chirurgie Instrumentation) Sas · 2020
Most influential descendants
Showing 1 of 1 · See all- K201606LacriJet®Fci (France Chirurgie Instrumentation) Sas · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K061404 | Mono-Crawford Naso-Lacrimal Intubation Device | Fci Ophthalmics, Inc. | 2006 | — |
| 0 (this device) | K113536 | Masterka 40 Masterka 35 Masterka 30 | Fci Sas (France Chirurgie Instrumentation) | 2012 | — |
| +1 | K201606 | LacriJet® | Fci (France Chirurgie Instrumentation) Sas | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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? (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 |
|---|---|---|---|
| * | K061404 | Mono-Crawford Naso-Lacrimal Intubation DeviceSummary page 1…The MASTERKAI® is substantially equivalent to the Mono-Crawford Naso-Lascrimal Intubation Device marketed by FCI Ophthalmics, Inc, 5 10(k) Premarket Notification Number: K061404, FDA Product Code OKS; and, to the Mini-Monoka monocanalicular probes marketed by FCI Ophthalmics, Inc, 5 10(k) Premarket Notific… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201606 | LacriJet® | 2020 | 0 |
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 MASTERKA®0 is a silicone intubation device indicated for use in the treatment of congenital lacrimal duct obstructions (stenosis of the valve of Hasner) in patients 12 months and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113536 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113536: Masterka 40 Masterka 35 Masterka 30.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113536
Report an extraction error
Are you the manufacturer?
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