Cleared Traditional

K023456 - OXYBOX SYSTEM

K023456 is an FDA 510(k) clearance for OXYBOX SYSTEM, manufactured by Oxyfast Corporation. The device is a Class 2 General & Plastic Surgery device with product code KPJ cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K023456 · Oxyfast Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
132d
Days
Class 2
Risk

K023456 is an FDA 510(k) clearance for the OXYBOX SYSTEM. Classified as Chamber, Oxygen, Topical, Extremity (product code KPJ), Class II - Special Controls.

Submitted by Oxyfast Corporation (Cleveland, US). The FDA issued a Cleared decision on February 24, 2003 after a review of 132 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5650 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K023456

510(k) Number K023456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2002
Decision Date February 24, 2003
Days to Decision 132 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 115d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPJ Device Classification - Class 2, Special Controls

Product Code KPJ Chamber, Oxygen, Topical, Extremity
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5650
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - KPJ Chamber, Oxygen, Topical, Extremity

All 22
Devices cleared under the same product code (KPJ) and FDA review panel - the closest regulatory comparables to K023456.
TANSCU O2
K090681 · Electrochemical Oxygen Concepts, Inc. · Aug 2009
HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM
K080966 · Aoti , Ltd. · Aug 2008
WHS-1000 WOUND HEALING SYSTEM
K050156 · Iyia Technologies, Inc. · Jun 2005
VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER
K022028 · Vascular One, Inc. · Dec 2002
HEC 1000
K020466 · Metro Medical Equipment, Inc. · May 2002
OXYGENATOR
K002632 · Adjunctive Therapeutics, Inc. · Oct 2001
K023456 · OXYBOX SYSTEM
Download PDF FDA Summary Oxyfast Corporation