FDA applicant

Anoxia Medical, Inc.

Hayward, CA2 decisions2023–20240 recalls

FDA records 2 decisions for Anoxia Medical, Inc. (Hayward, CA) from 2023 to 2024: 2 510(k) clearances. Most are in product codes QJP (Catheter, Percutaneous, Neurovasculature) and BTA (Pump, Portable, Aspiration (Manual Or Powered)). 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2024

2023high 1 (2023) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Anoxia Medical, Inc. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Anoxia Medical, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?