510(k) Report

FDA applicant

Scivolution, Inc.

Appollo Beach, FL1 decision2004–20040 recalls

FDA records 1 decision for Scivolution, Inc. (Appollo Beach, FL) in 2004: 1 510(k) clearance. All are in product code FRO (Dressing, Wound, Drug). Its devices cite 1 predicate, 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 Scivolution, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Scivolution, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Scivolution, 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?

  • FRODressing, Wound, Drug1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

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.

  • K032983Sensitive Skin Antibacterial BandagesScivolution, Inc. · 20041cites it

What has FDA decided for it lately?

  • K032983Sensitive Skin Antibacterial BandagesScivolution, Inc. · 2004

The one decision as Scivolution, Inc. →