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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / July 2026 / K261312

510(k) cleared

Temporary Keratoprosthesis (QuickSet TKP)

Eyekon Medical, Inc. · Jul 24, 2026 · K261312

FDA cleared the Temporary Keratoprosthesis (QuickSet TKP) from Eyekon Medical, Inc. on Jul 24, 2026 under K261312, a traditional 510(k). The device falls under product code MLP, Keratoprosthesis, Temporary Implant, Surgical Use, regulated at 21 CFR 886.3400 as a Class 2 device. The review panel was Ophthalmic.

FDA logged the submission as received on Apr 21, 2026. The decision came 94 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Eyekon Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261312?

K261312 is the FDA 510(k) for Temporary Keratoprosthesis (QuickSet TKP), submitted by Eyekon Medical, Inc.. FDA's decision date was Jul 24, 2026, under product code MLP (Keratoprosthesis, Temporary Implant, Surgical Use).

Who makes the Temporary Keratoprosthesis (QuickSet TKP)?

Eyekon Medical, Inc., based in Clearwater, FL, is the applicant of record for K261312.

How long did the K261312 review take?

FDA received the submission on Apr 21, 2026 and issued its decision on Jul 24, 2026, 94 days later.

← All decisions in July 2026