Cleared Traditional

K121203 - BOSTON KERATOPROSTHESIS OR BOSTON KPRO (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K121203 · Massachusetts Eye & Ear Infirmary · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
385d
Days
Class 2
Risk

K121203 is an FDA 510(k) clearance for the BOSTON KERATOPROSTHESIS OR BOSTON KPRO. Classified as Keratoprosthesis, Permanent Implant (product code HQM), Class II - Special Controls.

Submitted by Massachusetts Eye & Ear Infirmary (North Attleboro, US). The FDA issued a Cleared decision on May 10, 2013 after a review of 385 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3400 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Massachusetts Eye & Ear Infirmary devices

Submission Details

510(k) Number K121203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2012
Decision Date May 10, 2013
Days to Decision 385 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
275d slower than avg
Panel avg: 110d · This submission: 385d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQM Keratoprosthesis, Permanent Implant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.3400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.