510(k) Report

FDA applicant

Fidelty Hearing Instruments, Inc.

Mchenry, IL1 decision1983–19830 recalls

FDA records 1 decision for Fidelty Hearing Instruments, Inc. (Mchenry, IL) in 1983: 1 510(k) clearance. All are in product code FSD (Binder, Abdominal). 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, general hospital panel, where it files most

How often FDA has decided Fidelty Hearing Instruments, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Fidelty Hearing Instruments, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Fidelty Hearing Instruments, 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?

  • FSDBinder, Abdominal1decision

What has FDA decided for it lately?

  • K822817Doce All-in-the-Ear AidFidelty Hearing Instruments, Inc. · 1983

The one decision as Fidelty Hearing Instruments, Inc. →