510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K121203Substantially Equivalent

Boston Keratoprosthesis or Boston Kpro

Massachusetts Eye & Ear Infirmary, North Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K121203 is the FDA 510(k) clearance record for BOSTON KERATOPROSTHESIS OR BOSTON KPRO, a class II device, cleared for Massachusetts Eye & Ear Infirmary on under FDA product code HQM (Keratoprosthesis, Permanent Implant). FDA records list one 510(k) clearance for Massachusetts Eye & Ear Infirmary. As of , FDA records show no recalls naming K121203.

Clearance record

Decision date
Received
(385 days to decision)
Product code
HQM Keratoprosthesis, Permanent Implant
Regulation
21 CFR 886.3400
Device class
Class II
Review panel
Ophthalmic
Applicant
Massachusetts Eye & Ear Infirmary 49 Plain St., North Attleboro MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HQM

Trailing 12 months

FDA records hold no clearances under product code HQM in the trailing twelve months.

FDA records show no clearances under product code HQM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HQM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260