510(k) Report

FDA applicant

Gn Resound A/S

Ballerup, DK3 decisions2008–20150 recalls

FDA records 3 decisions for Gn Resound A/S (Ballerup, DK) from 2008 to 2015: 3 510(k) clearances. All are in product code KLW (Masker, Tinnitus). Its devices cite 4 predicates, 2 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 Gn Resound A/S’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2008: 12011: 12015: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Gn Resound A/S by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Gn Resound A/S’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

Which product codes does it file in?

  • KLWMasker, Tinnitus3decisions

Whose devices does it build on?

Its devices cite 4 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 times; 2 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.

  • K110932Tinnitus Sound Generator ModuleGn Resound A/S · 20117cite it
  • K073636Tinnitus Sound Generator ModuleGn Resound A/S · 20084cite it
  • K150171Tinnitus Sound Generator ModuleGn Resound A/S · 20151cites it

What has FDA decided for it lately?

  • K150171Tinnitus Sound Generator ModuleGn Resound A/S · 2015
  • K110932Tinnitus Sound Generator ModuleGn Resound A/S · 2011
  • K073636Tinnitus Sound Generator ModuleGn Resound A/S · 2008

All 3 as Gn Resound A/S →