FDA applicant

Apieron, Inc.

Menlo Park, CA2 decisions2008–20090 recalls

FDA records 2 decisions for Apieron, Inc. (Menlo Park, CA) from 2008 to 2009: 2 510(k) clearances. All are in product code MXA (System, Test, Breath Nitric Oxide). Its devices cite 1 predicate, 1 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, clinical toxicology panel, where it files most

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

FDA decisions per year

1in 2009

2008high 1 (2008) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

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

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Apieron, Inc.

Which product codes does it file in?

Which of its devices are cited most?

What has FDA decided for it lately?