510(k) Report

FDA applicant

Danavox, Inc.

Mchenry, IL26 decisions1977–19940 recalls

FDA records 26 decisions for Danavox, Inc. (Mchenry, IL) from 1977 to 1994: 26 510(k) clearances. Most are in product codes ESD (Hearing Aid, Air-Conduction, Prescription) and 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 Danavox, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Danavox, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Danavox, 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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