510(k) Report

FDA applicant

Spirosure, Inc.

Pleasanton, CA1 decision2019–20191 recall

FDA records 1 decision for Spirosure, Inc. (Pleasanton, CA) in 2019: 1 510(k) clearance. All are in product code MXA (System, Test, Breath Nitric Oxide). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 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 Spirosure, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2019: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

1in 2021

2021: 1
2019high 1 (2021) · low 0 (2019)2026

Class I Class II/III not classified

FIG. 1 — Spirosure, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MXASystem, Test, Breath Nitric Oxide1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K182874Fenom Pro Nitric Oxide TestSpirosure, Inc. · 20191cites it

What has FDA decided for it lately?

  • K182874Fenom Pro Nitric Oxide TestSpirosure, Inc. · 20191 recall

The one decision as Spirosure, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K182874CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable…Feb 26, 2021Class II