Cleared Traditional

K100823 - WOUND PRO APEX

K100823 is an FDA 510(k) clearance for WOUND PRO APEX, manufactured by Accuro Medical Products, LLC. The device is a Class 2 General & Plastic Surgery device with product code OMP cleared through the Traditional 510(k) pathway after a 306-day FDA review.

K100823 · Accuro Medical Products, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
306d
Days
Class 2
Risk

K100823 is an FDA 510(k) clearance for the WOUND PRO APEX. Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Accuro Medical Products, LLC (Denver, US). The FDA issued a Cleared decision on January 24, 2011 after a review of 306 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4780 - 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. Elevated predicate reliance profile. 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 Accuro Medical Products, LLC devices

FDA 510(k) Submission Details - K100823

510(k) Number K100823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2010
Decision Date January 24, 2011
Days to Decision 306 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
191d slower than avg
Panel avg: 115d · This submission: 306d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OMP Device Classification - Class 2, Special Controls

Product Code OMP Negative Pressure Wound Therapy Powered Suction Pump
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4780
Definition For Wound Management Via Application Of Continual Or Intermittent Negative Pressure To The Wound For Removal Of Fluids, Including Wound Exudate, Irrigation Fluids, And Infectious Materials. The Device Is Indicated For Management Of Chronic, Acute, Traumatic, Subacute And Dehisced Wounds, Partial-thickness Burns, Ulcers (such As Diabetic Or Pressure), Flaps And Grafts.
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 - OMP Negative Pressure Wound Therapy Powered Suction Pump

All 149
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K100823.
PICO
K111170 · Smith & Nephew, Inc. · Dec 2011
V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT
K111280 · Kci USA, Inc. · Jul 2011
RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD
K110647 · Smith & Nephew, Inc. · Jun 2011
MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY
K102001 · Smith & Nephew, Inc. · Aug 2010
A4-XLR8 FOAM DRESSING
K092992 · Genadyne Biotechnologies, Inc. · Jun 2010
PREVENA INCISION MANAGEMENT SYSTEM
K100821 · Kci USA, Inc. · Jun 2010