510(k) Report

FDA applicant

Cprx, LLC

Eden Prairie, MN1 decision2003–20030 recalls

FDA records 1 decision for Cprx, LLC (Eden Prairie, MN) in 2003: 1 510(k) clearance. All are in product code BWF (Spirometer, Therapeutic (Incentive)). 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Cprx, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • BWFSpirometer, Therapeutic (Incentive)1decision

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K022906Resqpod Circulatory EnhancerCprx, LLC · 20033cite it

What has FDA decided for it lately?

  • K022906Resqpod Circulatory EnhancerCprx, LLC · 2003

The one decision as Cprx, LLC →