FDA applicant

Spec Systems, Inc.

Mchenry, IL2 decisions1982–19880 recalls

FDA records 2 decisions for Spec Systems, Inc. (Mchenry, IL) from 1982 to 1988: 2 510(k) clearances. Most are in product codes ESD (Hearing Aid, Air-Conduction, Prescription) and FZH (Apparatus, Air Handling, Room). 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, ear, nose and throat panel, where it files most

How often FDA has decided Spec Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Spec Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Spec Systems, Inc.

Which product codes does it file in?

What has FDA decided for it lately?