510(k) Report

FDA applicant

Adm Tronics Unltd, Inc.

Morristown, TN1 decision1998–19980 recalls

FDA records 1 decision for Adm Tronics Unltd, Inc. (Morristown, TN) in 1998: 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 Adm Tronics Unltd, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Adm Tronics Unltd, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Adm Tronics Unltd, Inc. 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

Who builds on its devices?

Later devices cite its devices 2 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.

  • K981704AUREX-3Adm Tronics Unltd, Inc. · 19982cite it

What has FDA decided for it lately?

  • K981704AUREX-3Adm Tronics Unltd, Inc. · 1998

The one decision as Adm Tronics Unltd, Inc. →