# K261312: Temporary Keratoprosthesis (QuickSet TKP™)

- Pathway: 510(k) (Traditional)
- Applicant: Eyekon Medical, Inc.
- Decided: Jul 24, 2026 after 94 days
- Product code: MLP (Keratoprosthesis, Temporary Implant, Surgical Use)
- Device class: 2
- Regulation: 21 CFR 886.3400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K910828 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910828: Landers Wide Field Temporary Keratoprosthesis, Ocular Instruments, Inc. (1991) Summary page 6.

## Indications for use
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.

Source page: https://510kreport.com/device/K261312
Methodology: https://510kreport.com/methodology