510(k) Report

FDA applicant

Aureliym GmbH

Bad Neuenahr-Ahrweiler, DE1 decision2023–20230 recalls

FDA records 1 decision for Aureliym GmbH (Bad Neuenahr-Ahrweiler, DE) in 2023: 1 510(k) clearance. All are in product code KLW (Masker, Tinnitus). 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, ear, nose and throat panel, where it files most

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

FDA decisions per year

1in 2023

2023: 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

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

Planning a device like Aureliym GmbH’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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Which product codes does it file in?

  • KLWMasker, Tinnitus1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K221125SilentCloudAureliym GmbH · 20231cites it

What has FDA decided for it lately?

  • K221125SilentCloudAureliym GmbH · 2023

The one decision as Aureliym GmbH →