FDA applicant

Darmiyan, Inc.

Berkeley, CA1 decision2024–20240 recalls

FDA records 1 decision for Darmiyan, Inc. (Berkeley, CA) in 2024: 1 De Novo grant. All are in product code QWT (Prognostic Assessment Software Of Mild…). 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 Darmiyan, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

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

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

See the 510(k) Report

Darmiyan, Inc.

Which product codes does it file in?

What has FDA decided for it lately?