FDA applicant

Prodesse, Inc.

Waukesha, WI6 decisions2008–20090 recalls

FDA records 6 decisions for Prodesse, Inc. (Waukesha, WI) from 2008 to 2009: 6 510(k) clearances. Most are in product codes OCC (Respiratory Virus Panel Nucleic Acid Assay…) and OOU (Parainfluenza Multiplex Nucleic Acid Assay). Its devices cite 8 predicates, 2 of them its own earlier devices. 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, microbiology panel, where it files most

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

FDA decisions per year

3in 2009

2008high 3 (2008) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Prodesse, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Prodesse, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?