510(k) Report

FDA applicant

Eye Dynamics, Inc.

Torrance, CA1 decision1994–19940 recalls

FDA records 1 decision for Eye Dynamics, Inc. (Torrance, CA) in 1994: 1 510(k) clearance. All are in product code GWN (Nystagmograph). 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 Eye Dynamics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Eye Dynamics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Eye Dynamics, Inc.’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?

  • GWNNystagmograph1decision

Who builds on its devices?

Later devices cite its devices 2 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.

  • K925111House Infrared/Video Electronystagmograph SystemEye Dynamics, Inc. · 19942cite it

What has FDA decided for it lately?

  • K925111House Infrared/Video Electronystagmograph SystemEye Dynamics, Inc. · 1994

The one decision as Eye Dynamics, Inc. →