510(k) Report

FDA applicant

Insound Medical, Inc.

Newark, CA2 decisions2002–20081 recall

FDA records 2 decisions for Insound Medical, Inc. (Newark, CA) from 2002 to 2008: 2 510(k) clearances. All are in product code ESD (Hearing Aid, Air-Conduction, Prescription). Its devices cite 5 predicates, 1 of them its own earlier devices. 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, ear, nose and throat panel, where it files most

How often FDA has decided Insound Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2010

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

Class I Class II/III not classified

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

Planning a device like Insound Medical, 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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Which product codes does it file in?

  • ESDHearing Aid, Air-Conduction, Prescription2decisions

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 1 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.

  • K021867Insound XT Series Hearing AidInsound Medical, Inc. · 20023cite it
  • K081136Lyric Hearing AidInsound Medical, Inc. · 20081cites it

What has FDA decided for it lately?

  • K081136Lyric Hearing AidInsound Medical, Inc. · 20081 recall
  • K021867Insound XT Series Hearing AidInsound Medical, Inc. · 2002

All 2 as Insound Medical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K081136InSound Medical, Inc, Lyric in-canal hearing aid.Jan 19, 2010