510(k) · Cleared
ClearedTemporary Keratoprosthesis (QuickSet TKP™)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eyekon Medical, Inc. · MLP Keratoprosthesis, Temporary Implant, Surgical Use
Cleared on Jul 24, 2026 as substantially equivalent to K910828 (Ocular Instruments, Inc., 1991) after a 94-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Jul 24, 2026
- Review
- 94 days
- Class
- Class II
- Product code
- MLP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K910828 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK910828 Landers Wide Field Temporary KeratoprosthesisOcular Instruments, Inc. · 1991
- This deviceK261312 Temporary Keratoprosthesis (QuickSet TKP™)Eyekon Medical, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910828 | Landers Wide Field Temporary Keratoprosthesis | Ocular Instruments, Inc. | 1991 | — |
| 0 (this device) | K261312 | Temporary Keratoprosthesis (QuickSet TKP™) | Eyekon Medical, Inc. | 2026 | — |
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 MLP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K910828 | Landers Wide Field Temporary KeratoprosthesisSummary page 6…uickSet TKP™ Product Characteristic Comparison / Rationale (K910828) (K261312) Indications for Use Transparent optical pathway The QuickSet Temporary… | 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?
- Its one ancestor has no recall.
How does its category compare?
All MLP devicesMLP Keratoprosthesis, Temporary Implant, Surgical Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · MLP
1so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · MLP
Too few MLP 510(k)s in any year since 2007 to give a median.
Recalls per year · MLP
No recall names MLP since 2007.
Adverse event reports per year · MLP
1in 2008
MAUDE reports naming product code MLP, 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 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The QuickSet Temporary Keratoprosthesis (QuickSet TKP™) is a surgical aid to provide a transparent optical pathway that permits closed pars plana vitrectomy in eyes with abnormal corneas.
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/K261312 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261312: Temporary Keratoprosthesis (QuickSet TKP™).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261312
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026