Cleared Traditional

K152519 - MTR550 (Tentative) Antimicrobial Silver...

K152519 · Medical Technology Research, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
273d
Days
-
Risk

K152519 is an FDA 510(k) clearance for the MTR550 (Tentative) Antimicrobial Silver Wound Gel. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Medical Technology Research, Inc. (Woodburn, US). The FDA issued a Cleared decision on June 2, 2016 after a review of 273 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.

View all Medical Technology Research, Inc. devices

FDA 510(k) Submission Details - K152519

510(k) Number K152519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2015
Decision Date June 02, 2016
Days to Decision 273 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
158d slower than avg
Panel avg: 115d · This submission: 273d
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 238
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K152519.
Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL
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K150985 · Derma Sciences, Inc. · Nov 2015
MEDIHONEY WOUND DRESSINGS
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LUOFUCON SILVER FOAM DRESSING
K141619 · Huizhou Foryou Medical Devices Co., Ltd. · Apr 2015