Cleared Special

K182986 - Boston Keratoprosthesis, Type I Lucia

K182986 is an FDA 510(k) clearance for Boston Keratoprosthesis, manufactured by Massachusetts Eye and Ear Infirmary D/B/A Boston. The device is a Class 2 Ophthalmic device with product code HQM cleared through the Special 510(k) pathway after a 93-day FDA review.

K182986 · Massachusetts Eye and Ear Infirmary D/B/A Boston · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2019
Decision
93d
Days
Class 2
Risk

K182986 is an FDA 510(k) clearance for the Boston Keratoprosthesis, Type I Lucia. Classified as Keratoprosthesis, Permanent Implant (product code HQM), Class II - Special Controls.

Submitted by Massachusetts Eye and Ear Infirmary D/B/A Boston (Boston, US). The FDA issued a Cleared decision on January 30, 2019 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3400 - the FDA ophthalmic device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K182986

510(k) Number K182986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2018
Decision Date January 30, 2019
Days to Decision 93 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 110d · This submission: 93d
Pathway characteristics
Modification to existing cleared device.

HQM Device Classification - Class 2, Special Controls

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.

Regulatory Consultant

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Kristy Katzenmeyer-Pleuss

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

K182986 · Boston Keratoprosthesis, Type I Lucia
Download PDF FDA Summary Massachusetts Eye and…