510(k) · Cleared
ClearedBoston Keratoprosthesis or Boston Kpro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Massachusetts Eye & Ear Infirmary · HQM Keratoprosthesis, Permanent Implant
Cleared on May 10, 2013 as substantially equivalent to K915062 (Mackeen Consultants, Ltd., 1992) after a 385-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it.
- Decided
- May 10, 2013
- Review
- 385 days
- Class
- Class II
- Product code
- HQM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K915062 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK915062 Dohlman Doane KeratoprothesisMackeen Consultants, Ltd. · 1992
- This deviceK121203 Boston Keratoprosthesis or Boston KproMassachusetts Eye & Ear Infirmary · 2013
- Descendant · cites it directly · 0 of its ownK182986 Boston Keratoprosthesis, Type I LuciaMassachusetts Eye and Ear Infirmary D/B/A Boston · 2019
Most influential descendants
Showing 1 of 1 · See all- K182986Boston Keratoprosthesis, Type I LuciaMassachusetts Eye and Ear Infirmary D/B/A Boston · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915062 | Dohlman Doane Keratoprothesis | Mackeen Consultants, Ltd. | 1992 | — |
| 0 (this device) | K121203 | Boston Keratoprosthesis or Boston Kpro | Massachusetts Eye & Ear Infirmary | 2013 | — |
| +1 | K182986 | Boston Keratoprosthesis, Type I Lucia | Massachusetts Eye and Ear Infirmary D/B/A Boston | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
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 |
|---|---|---|---|
| * | K915062 | Dohlman Doane KeratoprothesisSummary page 1…886.3400 4. PREDICATE DEVICES Massachusetts Eye & Ear Infirmary's Keratoprosthesis previously cleared on January 21, 1992 under Premarket Notification Number K915062. 5. DEVICE DESCRIPTION The Boston Keratoprosthesis is an artificial comneal device that can be used in patients with severe… | 1992 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182986 | Boston Keratoprosthesis, Type I Lucia | 2019 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K182986 (Massachusetts Eye and Ear Infirmary D/B/A Boston, 2019) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HQM devicesHQM Keratoprosthesis, Permanent Implant: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Keratoprosthesis 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 as stated in the FDA summary.
https://510kreport.com/device/K121203 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121203: Boston Keratoprosthesis or Boston Kpro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121203
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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