510(k) Report

FDA applicant

Humboldt Products

Mchenry, IL5 decisions1980–19840 recalls

FDA records 5 decisions for Humboldt Products (Mchenry, IL) from 1980 to 1984: 5 510(k) clearances. Most are in product codes ETB (Prosthesis, Partial Ossicular Replacement) and ETD (Tube, Tympanostomy). 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, ear, nose and throat panel, where it files most

How often FDA has decided Humboldt Products’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Humboldt Products since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • ETBProsthesis, Partial Ossicular Replacement2decisions
  • ETDTube, Tympanostomy2decisions
  • GDGHook, Surgical, General & Plastic Surgery1decision

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.

  • K802587Otological Ventilation TubesHumboldt Products · 19801cites it

What has FDA decided for it lately?

  • K832540Drumto Stapes ProsthesisHumboldt Products · 1984
  • K823483Stainless Steel PistonsHumboldt Products · 1982
  • K813616Tekna Med Myringotomy Dispos-Oto KitHumboldt Products · 1982
  • K812562Surgical Retractor & Elastic Stays, DispHumboldt Products · 1981
  • K802587Otological Ventilation TubesHumboldt Products · 1980

All 5 as Humboldt Products →