FDA applicant

Beyond Air, Inc.

Garden City1 decision2022–20220 recalls

FDA records 1 decision for Beyond Air, Inc. (Garden City) in 2022: 1 original PMA approval. All are in product code QTB (Nitric Oxide Generator And Delivery System). 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 Beyond Air, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Beyond Air, Inc. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Beyond Air, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Beyond”

FDA records each applicant name separately; these may or may not be the same firm.

Beyond 21st Century, Inc. 1 Beyond 700 Pty, Ltd. 1

Beyond Air, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Beyond”