510(k) Report

FDA applicant

Dermagenics, Inc.

Memphis, TN1 decision2005–20050 recalls

FDA records 1 decision for Dermagenics, Inc. (Memphis, TN) in 2005: 1 510(k) clearance. All are in product code FRO (Dressing, Wound, Drug). 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 Dermagenics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dermagenics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Dermagenics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • 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.

  • K041059Epi-MaxDermagenics, Inc. · 20051cites it

What has FDA decided for it lately?

  • K041059Epi-MaxDermagenics, Inc. · 2005

The one decision as Dermagenics, Inc. →