Cleared Traditional

EPIFLO-28 (K190742) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence.

K190742 · Neogenix, LLC Dba Ogenix · General & Plastic Surgery device
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Dec 2019
Decision
266d
Days
Class 2
Risk

K190742 is an FDA 510(k) clearance for the EPIFLO-28. Classified as Chamber, Oxygen, Topical, Extremity (product code KPJ), Class II - Special Controls.

Submitted by Neogenix, LLC Dba Ogenix (Beachwood, US). The FDA issued a Cleared decision on December 13, 2019 after a review of 266 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 Neogenix, LLC Dba Ogenix devices

Submission Details

510(k) Number K190742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2019
Decision Date December 13, 2019
Days to Decision 266 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
151d slower than avg
Panel avg: 115d · This submission: 266d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01291160 Completed Interventional Industry-sponsored

Transdermal Continuous Oxygen Therapy for Diabetic Foot Ulcers

A Prospective, Randomized Blinded Multicenter, Parallel Study Comparing Transdermal, Continuous Oxygen Delivery to Moist Wound Therapy (MWT) in the Treatment of Diabetic Foot Ulcers

130
Patients (actual)
14
Sites
Treatment
Purpose
Triple
Masking
Condition studied Diabetic Foot Ulcers
Study design Parallel
Eligibility All sexes · 20 Years+
Principal investigator Vickie R Driver, MSDPM FACFAS
Sponsor Neogenix, LLC dba Ogenix (industry)
Started 2009-10-01 → Primary completion 2013-02-01
Primary outcome
Number of 100% Wound Closure
View full study on ClinicalTrials.gov