510(k) Report

FDA applicant

Tinnitech, Ltd.

Sydney, AU1 decision2003–20030 recalls

FDA records 1 decision for Tinnitech, Ltd. (Sydney, AU) in 2003: 1 510(k) clearance. All are in product code KLW (Masker, Tinnitus). Its devices cite 2 predicates, 0 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, ear, nose and throat panel, where it files most

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

FDA decisions per year

No FDA decision for Tinnitech, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Tinnitech, Ltd. 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

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 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.

  • K030791Anmp (Acoustic Neuro Modulation Protocol)Tinnitech, Ltd. · 20036cite it

What has FDA decided for it lately?

  • K030791Anmp (Acoustic Neuro Modulation Protocol)Tinnitech, Ltd. · 2003

The one decision as Tinnitech, Ltd. →