FDA applicant

Tympany, Inc.

Salt Lake City, UT2 decisions2004–20070 recalls

FDA records 2 decisions for Tympany, Inc. (Salt Lake City, UT) from 2004 to 2007: 2 510(k) clearances. Most are in product codes EWO (Audiometer) and ETW (Calibrator, Hearing Aid / Earphone And…). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Tympany, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Tympany, 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

Tympany, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?