510(k) Report

FDA applicant

Izun Pharmaceuticals Corporation

New York, NY2 decisions2011–20170 recalls

FDA records 2 decisions for Izun Pharmaceuticals Corporation (New York, NY) from 2011 to 2017: 2 510(k) clearances. Most are in product codes OLR (Oral Wound Dressing) and FRO (Dressing, Wound, Drug). No recall is linked to its devices.

FDA’s records also spell it “Izun Pharmaceuticals”.

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

How often FDA has decided Izun Pharmaceuticals Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2011: 12017: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Izun Pharmaceuticals Corporation by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OLROral Wound Dressing1decision
  • FRODressing, Wound, Drug1decision

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.

  • K103054PeriopatchIzun Pharmaceuticals Corporation · 20111cites it

What has FDA decided for it lately?

  • K161991CurasiteIzun Pharmaceuticals · 2017
  • K103054PeriopatchIzun Pharmaceuticals Corporation · 2011

The one decision as Izun Pharmaceuticals Corporation →The one decision as Izun Pharmaceuticals →