510(k) Report

FDA applicant

Neurosim Limited

Victoria, AU1 decision2002–20020 recalls

FDA records 1 decision for Neurosim Limited (Victoria, AU) in 2002: 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 Neurosim Limited’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Neurosim Limited since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Neurosim Limited by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KLWMasker, Tinnitus1decision

What has FDA decided for it lately?

  • K013827TST - Suppressor Model #1000Neurosim Limited · 2002

The one decision as Neurosim Limited →