510(k) Report

FDA applicant

Durden Enterprises, Inc.

Auburn, GA4 decisions1984–19910 recalls

FDA records 4 decisions for Durden Enterprises, Inc. (Auburn, GA) from 1984 to 1991: 4 510(k) clearances. Most are in product codes GWQ (Full-Montage Standard Electroencephalograph) and GXY (Electrode, Cutaneous). 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 Durden Enterprises, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Durden Enterprises, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Durden Enterprises, 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 Electroencephalograph1decision
  • GXYElectrode, Cutaneous1decision
  • KGXTape And Bandage, Adhesive1decision
  • FRODressing, Wound, Drug1decision

What has FDA decided for it lately?

  • K912160Butterfly DressingDurden Enterprises, Inc. · 1991
  • K891189Wedge Pressure DressingDurden Enterprises, Inc. · 1989
  • K883557Neurowave System 2Durden Enterprises, Inc. · 1988
  • K842271Electrode, Surface Eeg ElectrodeDurden Enterprises, Inc. · 1984

All 4 as Durden Enterprises, Inc. →