FDA applicant

Spectral Data Systems

Mchenry, IL2 decisions1983–19850 recalls

FDA records 2 decisions for Spectral Data Systems (Mchenry, IL) from 1983 to 1985: 2 510(k) clearances. All are in product code HCC (Device, Biofeedback). 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 Spectral Data Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Spectral Data Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Spectral Data Systems’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 “Spectral”

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

Spectral Diagnostics, Inc. 12 Spectral Medical, Inc. 2 Spectral Visualization & Development, Inc. 1

Spectral Data Systems

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Spectral”