FDA applicant

Breakthrough, Inc.

Oakdale, IA1 decision1992–19920 recalls

FDA records 1 decision for Breakthrough, Inc. (Oakdale, IA) in 1992: 1 510(k) clearance. All are in product code IKE (Transducer, Miniature Pressure). 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, physical medicine panel, where it files most

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

FDA decisions per year

No FDA decision for Breakthrough, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Breakthrough, Inc.

Which product codes does it file in?

What has FDA decided for it lately?