Cleared Traditional

V.A.C. ABDOMINAL DRESSING (K022011) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K022011 · Kinetic Concepts, Inc. · General & Plastic Surgery device
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Feb 2003
Decision
252d
Days
Class 2
Risk

K022011 is an FDA 510(k) clearance for the V.A.C. ABDOMINAL DRESSING. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Kinetic Concepts, Inc. (San Antonio, US). The FDA issued a Cleared decision on February 26, 2003 after a review of 252 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - 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 Kinetic Concepts, Inc. devices

Submission Details

510(k) Number K022011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2002
Decision Date February 26, 2003
Days to Decision 252 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
137d slower than avg
Panel avg: 115d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FTL Mesh, Surgical, Polymeric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
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 - FTL Mesh, Surgical, Polymeric

All 131
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K022011.
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
K032865 · W.L. Gore & Associates, Inc. · Nov 2003
PROCEED TRILAMINATE SURGICAL MESH
K031925 · Ethicon, Inc. · Sep 2003
GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL
K032168 · W.L. Gore & Associates, Inc. · Aug 2003
SMALL BARD VENTRALEX PATCH
K024008 · C.R. Bard, Inc. · Feb 2003
DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL
K022782 · W.L. Gore & Associates, Inc. · Sep 2002
BARD CRURASOFT PATCH, MODELS 0116003 & 0116001
K022350 · C.R. Bard, Inc. · Aug 2002