510(k) Report

FDA applicant

Medical Acoustics

Buffalo, NY2 decisions2006–20100 recalls

FDA records 2 decisions for Medical Acoustics (Buffalo, NY) from 2006 to 2010: 2 510(k) clearances. Most are in product codes BWF (Spirometer, Therapeutic (Incentive)) and BYI (Percussor, Powered-Electric). No recall is linked to its devices.

FDA’s records also spell it “Medical Acoustics, LLC”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

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

FDA decisions per year

1in 2010

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

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Medical Acoustics’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?

  • BWFSpirometer, Therapeutic (Incentive)1decision
  • BYIPercussor, Powered-Electric1decision

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.

  • K091557Lung Flute TherapeuticMedical Acoustics · 20101cites it

What has FDA decided for it lately?

  • K091557Lung Flute TherapeuticMedical Acoustics · 2010
  • K060439Lung FluteMedical Acoustics, LLC · 2006

The one decision as Medical Acoustics →The one decision as Medical Acoustics, LLC →