Data / Medical devices / United States / M.E.E.I. Boston Keratoprosthesis
M.E.E.I. Boston Keratoprosthesis: FDA-registered device maker in Boston, MA, United States, 3 510(k) clearances
M.E.E.I. Boston Keratoprosthesis is registered with the FDA (registration 1222945) in Boston, MA, United States. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated January 30, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1222945
- FEI number
- 1000120597
- Address
- 243 Charles ST, Boston, MA, United States, 02114
- Owner or operator
- MASSACHUSETTS EYE & EAR INFIRMARY (9004589)
- Roles
- Manufacturer
- First device listed
- October 23, 2007
- Registered through
- 2026
- Brand names listed
- Boston KPro, Boston Keratoprosthesis, Boston Keratoprosthesis type I Lucia
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Keratoprosthesis, Permanent Implant | HQM | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 30, 2019 | K182986 | Boston Keratoprosthesis, Type I Lucia | HQM | Substantially Equivalent | Massachusetts Eye and Ear Infirmary D/B/A Boston | accessdata.fda.gov |
| May 10, 2013 | K121203 | BOSTON KERATOPROSTHESIS OR BOSTON KPRO | HQM | Substantially Equivalent | Massachusetts Eye & Ear Infirmary | accessdata.fda.gov |
| January 21, 1992 | K915062 | DOHLMAN DOANE KERATOPROTHESIS | HQM | Substantially Equivalent | Mackeen Consultants, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated January 30, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.