Cleared Special

K120764 - EPIFLO(R)

K120764 is an FDA 510(k) clearance for EPIFLO, manufactured by Neogenix, LLC. The device is a Class 2 General & Plastic Surgery device with product code KPJ cleared through the Special 510(k) pathway after a 45-day FDA review.

K120764 · Neogenix, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
45d
Days
Class 2
Risk

K120764 is an FDA 510(k) clearance for the EPIFLO(R). Classified as Chamber, Oxygen, Topical, Extremity (product code KPJ), Class II - Special Controls.

Submitted by Neogenix, LLC (Beachwood, US). The FDA issued a Cleared decision on April 27, 2012 after a review of 45 days - a notably fast clearance 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K120764

510(k) Number K120764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2012
Decision Date April 27, 2012
Days to Decision 45 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 115d · This submission: 45d
Pathway characteristics
Modification to existing cleared device.

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 K120764.
VHT-200 Wound Treatment System
K212121 · Vaporox, Inc. · Mar 2023
EPIFLO-28
K190742 · Neogenix, LLC Dba Ogenix · Dec 2019
NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP
K112634 · Inotec Amd , Ltd. · Jul 2012
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
K120764 · EPIFLO(R)
Download PDF FDA Summary Neogenix, LLC