FDA applicant

Velmeni, Inc.

Sunnyvale, CA4 decisions2024–20260 recalls

FDA records 4 decisions for Velmeni, Inc. (Sunnyvale, CA) from 2024 to 2026: 4 510(k) clearances. Most are in product codes MYN (Analyzer, Medical Image) and QIH (Automated Radiological Image Processing Software). Since 2016 its 510(k)s took a median of 216 days from receipt to decision, against 130 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 2 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, radiology panel, where it files most

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

FDA decisions per year

1in 2025

2024high 2 (2026) · low 1 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Velmeni, Inc. by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Velmeni, 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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Velmeni, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?