510(k) Report

FDA applicant

Nuvoair AB

Stockholm, SE2 decisions2020–20240 recalls

FDA records 2 decisions for Nuvoair AB (Stockholm, SE) from 2020 to 2024: 2 510(k) clearances. All are in product code BZG (Spirometer, Diagnostic). Its devices cite 2 predicates, 0 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, anesthesiology panel, where it files most

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

FDA decisions per year

1in 2024

2020: 12024: 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Nuvoair AB by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • BZGSpirometer, Diagnostic2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 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.

  • K183089Air NextNuvoair AB · 20201cites it

What has FDA decided for it lately?

  • K231416Air Next (NVD-02)Nuvoair AB · 2024
  • K183089Air NextNuvoair AB · 2020

All 2 as Nuvoair AB →