Cleared Traditional

K132025 - MESO BILAYER SURGICAL MESH

K132025 is an FDA 510(k) clearance for MESO BILAYER SURGICAL MESH, manufactured by Kensey Nash Corporation Dba Dsm Biomedical. The device is a Class 2 General & Plastic Surgery device with product code FTM cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K132025 · Kensey Nash Corporation Dba Dsm Biomedical · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
121d
Days
Class 2
Risk

K132025 is an FDA 510(k) clearance for the MESO BILAYER SURGICAL MESH. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Kensey Nash Corporation Dba Dsm Biomedical (Exton, US). The FDA issued a Cleared decision on October 30, 2013 after a review of 121 days - within the typical 510(k) review window.

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 Kensey Nash Corporation Dba Dsm Biomedical devices

FDA 510(k) Submission Details - K132025

510(k) Number K132025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2013
Decision Date October 30, 2013
Days to Decision 121 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
6d slower than avg
Panel avg: 115d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTM Device Classification - Class 2, Special Controls

Product Code FTM Mesh, Surgical
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 - FTM Mesh, Surgical

All 151
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K132025.
SIS HERNIA GRAFT
K133306 · Cook Biotech, Inc. · Jul 2014
XENMATRIX SURGICAL GRAFT
K140501 · C. R. Bard · Apr 2014
MIROMATRIX BIOLOGICAL MESH
K134033 · Miromatrix Medical, Inc. · Mar 2014
ENDOFORM RECONSTRUCTIVE TEMPLATE
K130547 · Mesynthe, Ltd. · May 2013
FORTIVA PORCINE DERMIS
K123356 · Rti Biologics, Inc. · Mar 2013
COLLAGEN TENDON SHEET-D
K122048 · Rotation Medical, Inc. · Jan 2013