510(k) Report

FDA applicant

Ear Tech, Inc.

Bradenton, FL2 decisions1988–19930 recalls

FDA records 2 decisions for Ear Tech, Inc. (Bradenton, FL) from 1988 to 1993: 2 510(k) clearances. Most are in product codes ESD (Hearing Aid, Air-Conduction, Prescription) and JYG (Curette, Ear). 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 Ear Tech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ear Tech, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Ear Tech, 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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