FDA applicant

Rion Acoustic Instruments, Inc.

Mchenry, IL51 decisions1979–19880 recalls

FDA records 51 decisions for Rion Acoustic Instruments, Inc. (Mchenry, IL) from 1979 to 1988: 51 510(k) clearances. Most are in product codes ESD (Hearing Aid, Air-Conduction, Prescription) and GWO (Plate, Cranioplasty, Preformed, Alterable). 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 Rion Acoustic Instruments, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Rion Acoustic Instruments, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Rion Acoustic Instruments, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Rion”

FDA records each applicant name separately; these may or may not be the same firm.

Rion Co. Ltd. Dba Rion Acoustic Device 2

Rion Acoustic Instruments, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Rion”