Cleared Traditional

K100029 - MEPILEX BORDER AG DRESSING

K100029 · Molnlycke Health Care · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
252d
Days
-
Risk

K100029 is an FDA 510(k) clearance for the MEPILEX BORDER AG DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Molnlycke Health Care (Norcross, US). The FDA issued a Cleared decision on September 15, 2010 after a review of 252 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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.

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FDA 510(k) Submission Details - K100029

510(k) Number K100029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2010
Decision Date September 15, 2010
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.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 242
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K100029.
PRONTOSAN WOUND IRRIGATION SOLUTION
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PRONTOSAN ANTIMICROBIAL WOUND GEL
K101882 · B.Braun Medical, Inc. · Nov 2010
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MEDLINE CURAD WOUND DRESSINGS
K093349 · Medline Industries, Inc. · Jan 2010
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K083113 · Smith & Nephew, Inc. · Jul 2009