510(k) Report

FDA applicant

Dade Medical, Inc.

Mchenry, IL1 decision1981–19810 recalls

FDA records 1 decision for Dade Medical, Inc. (Mchenry, IL) in 1981: 1 510(k) clearance. All are in product code GWS (Analyzer, Spectrum, Electroencephalogram Signal). 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 Dade Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dade Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Dade Medical, 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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Other applicant names beginning “Dade”

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