510(k) Report

FDA applicant

Euro-Am Pharma, Inc.

Fanwood, NJ2 decisions1990–19910 recalls

FDA records 2 decisions for Euro-Am Pharma, Inc. (Fanwood, NJ) from 1990 to 1991: 2 510(k) clearances. Most are in product codes BTM (Ventilator, Emergency, Manual (Resuscitator)) and MVV (Device, Acupressure). 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 Euro-Am Pharma, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Euro-Am Pharma, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Euro-Am Pharma, Inc.’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?

  • BTMVentilator, Emergency, Manual (Resuscitator)1decision
  • MVVDevice, Acupressure1decision

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.

  • K900588Acu-Band Accupressure Wrist BandEuro-Am Pharma, Inc. · 19901cites it

What has FDA decided for it lately?

  • K912620Opomat Manual Resuscitator VentilatorEuro-Am Pharma, Inc. · 1991
  • K900588Acu-Band Accupressure Wrist BandEuro-Am Pharma, Inc. · 1990

All 2 as Euro-Am Pharma, Inc. →