510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K261312Substantially Equivalent

Temporary Keratoprosthesis (QuickSet TKP™)

Eyekon Medical, Inc., Clearwater FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K261312 is the FDA 510(k) clearance record for Temporary Keratoprosthesis (QuickSet TKP™), a class II device, cleared for Eyekon Medical, Inc. on under FDA product code MLP (Keratoprosthesis, Temporary Implant, Surgical Use). FDA records list one 510(k) clearance for Eyekon Medical, Inc. As of , FDA records show no recalls naming K261312.

Clearance record

Decision date
Received
(94 days to decision)
Product code
MLP Keratoprosthesis, Temporary Implant, Surgical Use
Regulation
21 CFR 886.3400
Device class
Class II
Review panel
Ophthalmic
Applicant
Eyekon Medical, Inc. 2451 Enterprise Rd., Clearwater FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MLP

Trailing 12 months
1 clearance under product code MLP in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MLP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260