# K182986: Boston Keratoprosthesis, Type I Lucia

- Pathway: 510(k) (Special)
- Applicant: Massachusetts Eye and Ear Infirmary D/B/A Boston
- Decided: Jan 30, 2019 after 93 days
- Product code: HQM (Keratoprosthesis, Permanent Implant)
- Device class: 2
- Regulation: 21 CFR 886.3400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K915062 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121203: Boston Keratoprosthesis or Boston Kpro, Massachusetts Eye & Ear Infirmary (2013) Summary page 4.

## Indications for use
The Boston KPro is indicated to provide a transparent optical pathway through an opacified cornea in an eye that is not a reasonable candidate for any form of corneal transplant, including penetrating keratoplasty.

Source page: https://510kreport.com/device/K182986
Methodology: https://510kreport.com/methodology