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Oxybox System

by Oxyfast Corporation 510(k)

Active United States

510(k) K023456

Overview

The Oxybox System is a topical oxygen extremity chamber designed as a bandage system. It incorporates a disposable oxygen concentrator, a sterile cannula, and a wound dressing to provide topical oxygen therapy.

This device is supplied as a system consisting of three separate component parts, including medical grade commercial products. It is regulated under FDA 510(k) number K023456 and falls under regulation number 878.5650.

AI-generated from registry data, 25 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK023456 Date24 Feb 2003ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

2 recalls · FDA

    • Terminated Z-1477-2012 FDA Not yet classified initiated 16 Apr 2012

    Ogenix Initiated a voluntary recall for the EPIFLO-15 devices due to a mislabeling of the expiry date for this lot. Instead of March 2013, this lot carried May 2013 as the expiry date.

    • Terminated Z-1526-06 FDA Unclassified (pre-2012) initiated 24 Mar 2006

    Conflicting instructions are provided in the Instructions for Use (IFU) and the Clinical Users Guide (CUG) which accompany the EpiFLO device. Consequently, the firm removed the CUG from distribution.

Specification

510(k)

510(k) Number
FDA Product Code
KPJ
Device Class
Class II
Regulation
21 CFR Part 878.5650
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Questions

  • What components are included in the Oxybox System?

    The system is supplied as a comprehensive kit consisting of three separate component parts: a disposable oxygen concentrator, a sterile cannula, and a wound dressing.

  • What is the primary function of the Oxybox System?

    The Oxybox System is designed to function as a topical oxygen extremity chamber in the form of a bandage system, which allows for the delivery of topical oxygen therapy to the affected area.

  • What is the regulatory status of this device?

    The Oxybox System is regulated under FDA 510(k) number K023456 and is classified under regulation number 878.5650, which pertains to topical oxygen extremity chambers.