510(k) Report

FDA applicant

Neuroconcepts, Inc.

Middleton, WI3 decisions1991–19950 recalls

FDA records 3 decisions for Neuroconcepts, Inc. (Middleton, WI) from 1991 to 1995: 3 510(k) clearances. Most are in product codes GWQ (Full-Montage Standard Electroencephalograph) and OLT (Non-Normalizing Quantitative…). 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, neurology panel, where it files most

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

FDA decisions per year

No FDA decision for Neuroconcepts, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Neuroconcepts, Inc. 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?

  • GWQFull-Montage Standard Electroencephalograph2decisions
  • OLTNon-Normalizing Quantitative Electroencephalograph Software1decision

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.

  • K905435UniquantNeuroconcepts, Inc. · 19911cites it

What has FDA decided for it lately?

  • K951507Principle Component Eeg Analysis SoftwareNeuroconcepts, Inc. · 1995
  • K951724Quantitative Eeg Analysis SoftwareNeuroconcepts, Inc. · 1995
  • K905435UniquantNeuroconcepts, Inc. · 1991

All 3 as Neuroconcepts, Inc. →