510(k) Report

FDA applicant

Neuroscan

El Paso, TX3 decisions2000–20030 recalls

FDA records 3 decisions for Neuroscan (El Paso, TX) from 2000 to 2003: 3 510(k) clearances. Most are in product codes GWQ (Full-Montage Standard Electroencephalograph) and GXY (Electrode, Cutaneous). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Neuroscan’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Neuroscan since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • GWQFull-Montage Standard Electroencephalograph1decision
  • GXYElectrode, Cutaneous1decision
  • OLTNon-Normalizing Quantitative Electroencephalograph Software1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 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.

  • K023771SYNAMPS2Neuroscan · 20032cite it
  • K000865Quik-CapNeuroscan · 20002cite it
  • K023536NuampsNeuroscan · 20031cites it

What has FDA decided for it lately?

All 3 as Neuroscan →