510(k) · Cleared
ClearedBoston Keratoprosthesis, Type I Lucia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Massachusetts Eye and Ear Infirmary D/B/A Boston · HQM Keratoprosthesis, Permanent Implant
Cleared on Jan 30, 2019 as substantially equivalent to K121203 (Massachusetts Eye & Ear Infirmary, 2013) after a 93-day review. Its family tree reaches back 2 generations to 1992.
- Decided
- Jan 30, 2019
- Review
- 93 days
- Class
- Class II
- Product code
- HQM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K915062 (1992). No later device cites it as a predicate yet.
- Root · 2 generations backK915062 Dohlman Doane KeratoprothesisMackeen Consultants, Ltd. · 1992
- 1 generation backK121203 Boston Keratoprosthesis or Boston KproMassachusetts Eye & Ear Infirmary · 2013
- This deviceK182986 Boston Keratoprosthesis, Type I LuciaMassachusetts Eye and Ear Infirmary D/B/A Boston · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K915062 | Dohlman Doane Keratoprothesis | Mackeen Consultants, Ltd. | 1992 | — |
| −1 | K121203 | Boston Keratoprosthesis or Boston Kpro | Massachusetts Eye & Ear Infirmary | 2013 | — |
| 0 (this device) | K182986 | Boston Keratoprosthesis, Type I Lucia | Massachusetts Eye and Ear Infirmary D/B/A Boston | 2019 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HQM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K121203 | Boston Keratoprosthesis or Boston KproSummary page 4…CFR 886.3400 Product Code: HQM Predicate Device: Boston Keratoprosthesis (Boston KPro), Type I (Click-on design) K121203 Cleared on May 10, 2013 Device Description: The subject of this Special 510(k) is a modification of the Bos… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 21.3 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All HQM devicesHQM Keratoprosthesis, Permanent Implant: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · HQM
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · HQM
Too few HQM 510(k)s in any year since 2007 to give a median.
Recalls per year · HQM
No recall names HQM since 2007.
Adverse event reports per year · HQM
3in 2013
MAUDE reports naming product code HQM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K182986 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182986: Boston Keratoprosthesis, Type I Lucia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182986
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026