510(k) Report

FDA applicant

Oxyfast Corporation

Cleveland, OH1 decision2003–20032 recalls

FDA records 1 decision for Oxyfast Corporation (Cleveland, OH) in 2003: 1 510(k) clearance. All are in product code KPJ (Chamber, Oxygen, Topical, Extremity). Its devices cite 1 predicate, 0 of them its own earlier devices. 2 recalls are 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 and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Oxyfast Corporation since 2007.

Recalls per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Oxyfast 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?

  • KPJChamber, Oxygen, Topical, Extremity1decision

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 3 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.

  • K023456Oxybox SystemOxyfast Corporation · 20033cite it

What has FDA decided for it lately?

  • K023456Oxybox SystemOxyfast Corporation · 20032 recalls

The one decision as Oxyfast Corporation →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K023456EPIFLO; Transdermal continuous oxygen therapy device; single use; disposable medical…Apr 16, 2012
  • K023456Clinical Users Guide (CUG) accompanying the EpiFLO SD, Part #01-100-1000000. The EpiFLO…Mar 24, 2006