FDA applicant

Healstone Biotech, Inc.

Vancouver, CA3 decisions2019–20220 recalls

FDA records 3 decisions for Healstone Biotech, Inc. (Vancouver, CA) from 2019 to 2022: 3 510(k) clearances. Most are in product codes NFT (Test, Amphetamine, Over The Counter) and LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). Its devices cite 3 predicates, 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 Healstone Biotech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2022

2019high 2 (2022) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

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

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Healstone Biotech, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?