510(k) · Cleared
ClearedAlphacor; Alphacor-a (for Ahakic Eyes); Alphacor-P (for Phakic or Pseudophakic Eyes)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Argus Biomedical Pty, Ltd. · HQM Keratoprosthesis, Permanent Implant
Cleared on Aug 29, 2002 after a 289-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Aug 29, 2002
- Review
- 289 days
- Class
- Class II
- Product code
- HQM
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK013756 Alphacor; Alphacor-a (for Ahakic Eyes); Alphacor-P (for Phakic or…Argus Biomedical Pty, Ltd. · 2002
- Descendant · cites it directly · 0 of its ownK053298 Alphasphere Orbital ImplantHydron Pty Limited · 2006
Most influential descendants
Showing 1 of 1 · See all- K053298Alphasphere Orbital ImplantHydron Pty Limited · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013756 | Alphacor; Alphacor-a (for Ahakic Eyes); Alphacor-P (for Phakic or Pseudophakic… | Argus Biomedical Pty, Ltd. | 2002 | — |
| +1 | K053298 | Alphasphere Orbital Implant | Hydron Pty Limited | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 |
|---|---|---|---|
| * | — | Dohlman Doane Type I Keratoprosthesis Named without a submission number |
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 |
|---|---|---|---|
| K053298 | Alphasphere Orbital Implant | 2006 | 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?
- Of its descendants, K053298 (Hydron Pty Limited, 2006) 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.
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?
Adult patients with corneal opacity not suitable for standard penetrating keratoplasty.,with donor tissues, or where donor tissue has been declined, or where adjunctive measures required to prevent graft rejection are medically contraindicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K013756 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013756: Alphacor; Alphacor-a (for Ahakic Eyes); Alphacor-P (for Phakic or Pseudophakic Eyes).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013756
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026