Cleared Traditional

K140510 - MIROMATRIX WOUND MATRIX

K140510 · Miromatrix Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
111d
Days
-
Risk

K140510 is an FDA 510(k) clearance for the MIROMATRIX WOUND MATRIX. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Miromatrix Medical, Inc. (Alexandria, US). The FDA issued a Cleared decision on June 19, 2014 after a review of 111 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K140510

510(k) Number K140510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2014
Decision Date June 19, 2014
Days to Decision 111 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
4d faster than avg
Panel avg: 115d · This submission: 111d
Pathway characteristics
Predicate-based equivalence.

KGN Device Classification - Class 0,

Product Code KGN Wound Dressing With Animal-derived Material(s)
Device Class -

Regulatory Peers - KGN Wound Dressing With Animal-derived Material(s)

All 182
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K140510.
ARCHITECT PX EXTRACELLULAR COLLAGEN MATRIX
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K134037 · Biotime, Inc. · Aug 2014
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K140456 · MLM Biologics, Inc. · Jul 2014
COLLACARE DENTAL
K133290 · Innocoll Pharmaceuticals · May 2014
MARIGEN WOUND DRESSING
K132343 · Kerecis Limited · Oct 2013
COVAGEN
K123756 · Covalon Technologies, Ltd. · Aug 2013