510(k) Report

FDA applicant

Brasamerica Medical Equipment, Inc.

Great Neck,, NY2 decisions1997–19980 recalls

FDA records 2 decisions for Brasamerica Medical Equipment, Inc. (Great Neck,, NY) from 1997 to 1998: 2 510(k) clearances. All are in product code CAF (Nebulizer (Direct Patient Interface)). Its devices cite 1 predicate, 1 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Brasamerica Medical Equipment, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • CAFNebulizer (Direct Patient Interface)2decisions

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K972371Icel Ultrasonic Nebulizer Models PU 12000 Air and PU 12300 AirBrasamerica Medical Equipment, Inc. · 19971cites it

What has FDA decided for it lately?

  • K983736Icel Evolusonic Portable Ultrasonic NebulizerBrasamerica Medical Equipment, Inc. · 1998
  • K972371Icel Ultrasonic Nebulizer Models PU 12000 Air and PU 12300 AirBrasamerica Medical Equipment, Inc. · 1997

All 2 as Brasamerica Medical Equipment, Inc. →