510(k) Report

FDA applicant

Sonamed Corp.

Weston, MA1 decision1995–19951 recall

FDA records 1 decision for Sonamed Corp. (Weston, MA) in 1995: 1 510(k) clearance. All are in product code GWJ (Stimulator, Auditory, Evoked Response). 1 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, neurology panel, where it files most

How often FDA has decided Sonamed Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sonamed Corp. since 2007.

Recalls per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Sonamed Corp.’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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Which product codes does it file in?

  • GWJStimulator, Auditory, Evoked Response1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K952080Clarity System IISonamed Corp. · 19951cites it

What has FDA decided for it lately?

  • K952080Clarity System IISonamed Corp. · 19951 recall

The one decision as Sonamed Corp. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K952080SonaMed Clarity System II; evoked response auditory stimulator; SonaMed Corp., Waltham…Jun 4, 2010