Cleared Traditional

K022028 - VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER

K022028 is an FDA 510(k) clearance for VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER, manufactured by Vascular One, Inc.. The device is a Class 2 General & Plastic Surgery device with product code KPJ cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K022028 · Vascular One, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Dec 2002
Decision
179d
Days
Class 2
Risk

K022028 is an FDA 510(k) clearance for the VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER. Classified as Chamber, Oxygen, Topical, Extremity (product code KPJ), Class II - Special Controls.

Submitted by Vascular One, Inc. (Great Neck, US). The FDA issued a Cleared decision on December 17, 2002 after a review of 179 days - an extended review cycle.

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.

View all Vascular One, Inc. devices

FDA 510(k) Submission Details - K022028

510(k) Number K022028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2002
Decision Date December 17, 2002
Days to Decision 179 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 115d · This submission: 179d
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 12
Devices cleared under the same product code (KPJ) and FDA review panel - the closest regulatory comparables to K022028.
EPIFLO-28
K190742 · Neogenix, LLC Dba Ogenix · Dec 2019
NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP
K112634 · Inotec Amd , Ltd. · Jul 2012
EPIFLO(R)
K120764 · Neogenix, LLC · Apr 2012
NUMOBAG
K981949 · Numotech, Inc. · Feb 1999
O2 BOOT
K971507 · Gwr Medical, Llp · Nov 1997
LIFETECH CASSETTE
K960756 · Lifetech Systems, Inc. · Aug 1997