510(k) Report

FDA applicant

Xltek

Oakville, CA3 decisions2000–20020 recalls

FDA records 3 decisions for Xltek (Oakville, CA) from 2000 to 2002: 3 510(k) clearances. Most are in product codes GWQ (Full-Montage Standard Electroencephalograph) and GWF (Stimulator, Electrical, Evoked Response). 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 Xltek’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Xltek since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Xltek 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
  • GWFStimulator, Electrical, Evoked Response1decision

Whose devices does it build on?

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

What has FDA decided for it lately?

  • K01414684 Channel EegXltek · 2002
  • K01414780 Channel EegXltek · 2002
  • K002969Xltek Evoked Potential Headbox, Model EP-8Xltek · 2000

All 3 as Xltek →