510(k) Report

FDA applicant

Bio-Scan, Inc.

Mchenry, IL6 decisions1984–20010 recalls

FDA records 6 decisions for Bio-Scan, Inc. (Mchenry, IL) from 1984 to 2001: 6 510(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 Bio-Scan, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bio-Scan, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Bio-Scan, 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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