510(k) Report

FDA applicant

Neurodiagnostics, Inc.

Mchenry, IL4 decisions1980–19840 recalls

FDA records 4 decisions for Neurodiagnostics, Inc. (Mchenry, IL) from 1980 to 1984: 4 510(k) clearances. Most are in product codes GWK (Conditioner, Signal, Physiological) and GWE (Stimulator, Photic, Evoked Response). 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 Neurodiagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Neurodiagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Neurodiagnostics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report