510(k) Report

510(k) · Cleared

Cleared

Dohlman Doane Keratoprothesis

K915062510(k) TraditionalCleared Jan 21, 199274-day reviewClass II21 CFR 886.3400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Mackeen Consultants, Ltd. · HQM Keratoprosthesis, Permanent Implant

Cleared on Jan 21, 1992 after a 74-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided
Jan 21, 1992
Review
74 days
Class
Class II
Product code
HQM
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2013: 1 descendant cleared2019: 1 descendant cleared1990200020102020
  1. This deviceK915062 Dohlman Doane KeratoprothesisMackeen Consultants, Ltd. · 1992
  2. Descendant · cites it directly · 1 of its ownK121203 Boston Keratoprosthesis or Boston KproMassachusetts Eye & Ear Infirmary · 2013
  3. Descendant · 2 generations on · 0 of its ownK182986 Boston Keratoprosthesis, Type I LuciaMassachusetts Eye and Ear Infirmary D/B/A Boston · 2019

Most influential descendants

Showing 2 of 2 · See all
  • K121203Boston Keratoprosthesis or Boston KproMassachusetts Eye & Ear Infirmary · 2013 · cites it directly1descendant
  • K182986Boston Keratoprosthesis, Type I LuciaMassachusetts Eye and Ear Infirmary D/B/A Boston · 2019 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K915062Dohlman Doane KeratoprothesisMackeen Consultants, Ltd.1992—
+1K121203Boston Keratoprosthesis or Boston KproMassachusetts Eye & Ear Infirmary2013—
+2K182986Boston Keratoprosthesis, Type I LuciaMassachusetts Eye and Ear Infirmary D/B/A Boston2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201910
FIG. 1 — Lineage of K915062, 1992–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K121203Boston Keratoprosthesis or Boston KproMassachusetts Eye & Ear Infirmary20131

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, K121203 (Massachusetts Eye & Ear Infirmary, 2013) has gone furthest, with 1 descendant of its own.

How does its category compare?

All HQM devices

HQM Keratoprosthesis, Permanent Implant: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HQM

1in 2019

2013: 12019: 1
2007high 1 (2013) · low 0 (2007)2026

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

2013: 3
2007high 3 (2013) · low 0 (2007)2025

MAUDE reports naming product code HQM, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20131—03
20140—00
20150—00
20160—00
20170—00
20180—00
20191—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Mackeen Consultants, Ltd.

2 FDA decisions under this applicant name. See the company

  • K852737LactoplateMackeen Consultants, Ltd. · 1985

Recent decisions in HQM

The HQM category page

  • K182986Boston Keratoprosthesis, Type I LuciaMassachusetts Eye and Ear Infirmary D/B/A Boston · 2019
  • K121203Boston Keratoprosthesis or Boston KproMassachusetts Eye & Ear Infirmary · 2013
  • K013756Alphacor; Alphacor-a (for Ahakic Eyes); Alphacor-P (for Phakic or Pseudophakic Eyes)Argus Biomedical Pty, Ltd. · 2002

https://510kreport.com/device/K915062 · printed Nov 5, 2026

Cite this page

510(k) Report. “K915062: Dohlman Doane Keratoprothesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K915062

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026