510(k) Report

FDA applicant

Mackeen Consultants, Ltd.

Bethesda, MD2 decisions1985–19920 recalls

FDA records 2 decisions for Mackeen Consultants, Ltd. (Bethesda, MD) from 1985 to 1992: 2 510(k) clearances. Most are in product codes HQM (Keratoprosthesis, Permanent Implant) and DEG (Lactoferrin, Antigen, Antiserum, Control). No recall is linked to its devices.

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

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Mackeen Consultants, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mackeen Consultants, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mackeen Consultants, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Mackeen Consultants, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • HQMKeratoprosthesis, Permanent Implant1decision
  • DEGLactoferrin, Antigen, Antiserum, Control1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K915062Dohlman Doane KeratoprothesisMackeen Consultants, Ltd. · 19921cites it

What has FDA decided for it lately?

  • K915062Dohlman Doane KeratoprothesisMackeen Consultants, Ltd. · 1992
  • K852737LactoplateMackeen Consultants, Ltd. · 1985

All 2 as Mackeen Consultants, Ltd. →