510(k) Report

FDA applicant

Ceragenix Corporation

Denver, CO1 decision2006–20060 recalls

FDA records 1 decision for Ceragenix Corporation (Denver, CO) in 2006: 1 510(k) clearance. All are in product code FRO (Dressing, Wound, Drug). Its devices cite 4 predicates, 0 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

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

FDA decisions per year

No FDA decision for Ceragenix Corporation since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ceragenix Corporation 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?

  • FRODressing, Wound, Drug1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 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.

  • K052643EpiceramCeragenix Corporation · 20069cite it

What has FDA decided for it lately?

  • K052643EpiceramCeragenix Corporation · 2006

The one decision as Ceragenix Corporation →