FDA applicant

Vein 360, LLC

Blue Ash, OH5 decisions2019–20260 recalls

FDA records 5 decisions for Vein 360, LLC (Blue Ash, OH) from 2019 to 2026: 5 510(k) clearances. Most are in product codes OWQ (Reprocessed Intravascular Ultrasound Catheter) and NUJ (Electrosurgical, Cutting & Coagulation…). Since 2016 its 510(k)s took a median of 120 days from receipt to decision, against 78 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Vein 360”.

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 Vein 360, LLC’s devices, and how often a recall has named them.

FDA decisions per year

3in 2023

2019high 3 (2023) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Vein 360, LLC by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Vein 360, LLC

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

What has FDA decided for it lately?