FDA applicant

Neuspera Medical, Inc.

San Jose, CA3 decisions2021–20250 recalls

FDA records 3 decisions for Neuspera Medical, Inc. (San Jose, CA) from 2021 to 2025: 2 510(k) clearances and 1 original PMA approval. Most are in product codes GZF (Stimulator, Peripheral Nerve, Implanted (Pain…) and EZW (Stimulator, Electrical, Implantable, For…). Its devices cite 2 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, neurology panel, where it files most

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

FDA decisions per year

1in 2025

2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Neuspera Medical, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Neuspera Medical, 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?