510(k) Report

FDA applicant

Cleveland Clinic Foundation

Cleveland, OH1 decision1995–19950 recalls

FDA records 1 decision for Cleveland Clinic Foundation (Cleveland, OH) in 1995: 1 510(k) clearance. All are in product code GWQ (Full-Montage Standard Electroencephalograph). 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 Cleveland Clinic Foundation’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cleveland Clinic Foundation since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cleveland Clinic Foundation 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

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.

  • K941551The Vanguard SystemCleveland Clinic Foundation · 19951cites it

What has FDA decided for it lately?

  • K941551The Vanguard SystemCleveland Clinic Foundation · 1995

The one decision as Cleveland Clinic Foundation →

Other applicant names beginning “Cleveland”

FDA records each applicant name separately; these may or may not be the same firm.

Cleveland Medical Devices, Inc. 8Cleveland Tubing, Inc. 4Cleveland Diagnostics, Inc. 1Cleveland Medical Supply & Services 1Cleveland Clinic 1