FDA applicant

Nuwellis, Inc.

Eden Prairie, MN2 decisions2023–20250 recalls

FDA records 2 decisions for Nuwellis, Inc. (Eden Prairie, MN) from 2023 to 2025: 2 510(k) clearances. All are in product code NQJ (Catheter, Hemodialysis, Non-Implanted…). Its devices cite 3 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

1in 2025

2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Nuwellis, Inc. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nuwellis, 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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Nuwellis, 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?