FDA applicant

Preventiongenetics, LLC

Marshfield, WI1 decision2022–20220 recalls

FDA records 1 decision for Preventiongenetics, LLC (Marshfield, WI) in 2022: 1 De Novo grant. All are in product code QRV (Setmelanotide Eligibility Gene Variant…). 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 chemistry panel, where it files most

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

FDA decisions per year

1in 2022

2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Preventiongenetics, LLC by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Preventiongenetics, LLC’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

Preventiongenetics, LLC

Which product codes does it file in?

What has FDA decided for it lately?