510(k) Report

FDA applicant

Appro Healthcare, Inc.

Buffalo, NY2 decisions2002–20030 recalls

FDA records 2 decisions for Appro Healthcare, Inc. (Buffalo, NY) from 2002 to 2003: 2 510(k) clearances. Most are in product codes MRZ (Accessories, Pump, Infusion) and FPA (Set, Administration, Intravascular). 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Appro Healthcare, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Appro Healthcare, 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?

  • MRZAccessories, Pump, Infusion1decision
  • FPASet, Administration, Intravascular1decision

What has FDA decided for it lately?

  • K023890Prepare CartridgeAppro Healthcare, Inc. · 2003
  • K023769Prepare Administration SetAppro Healthcare, Inc. · 2002

All 2 as Appro Healthcare, Inc. →