FDA applicant

Smec, Inc.

Mchenry, IL7 decisions1980–19850 recalls

FDA records 7 decisions for Smec, Inc. (Mchenry, IL) from 1980 to 1985: 7 510(k) clearances. All are in product code DSP (System, Balloon, Intra-Aortic And Control). 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Smec, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Smec, 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

Smec, Inc.

Which product codes does it file in?

What has FDA decided for it lately?