Cleared Traditional

K070557 - MP 719

K070557 · Marine Polymer Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
85d
Days
-
Risk

K070557 is an FDA 510(k) clearance for the MP 719. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Marine Polymer Technologies, Inc. (Topsfield, US). The FDA issued a Cleared decision on May 23, 2007 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K070557

510(k) Number K070557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2007
Decision Date May 23, 2007
Days to Decision 85 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 115d · This submission: 85d
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 638
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K070557.
HONEY ALGINATE DRESSING
K053095 · Derma Sciences Canada, Inc. · Jul 2007
ACRYDERM SILVER ANTIMICROBIAL OTC WOUND GEL
K070333 · Acrymed, Inc. · Jul 2007
SILVACIDE SKIN & WOUND MOISTURIZING SOLUTION
K063063 · Medical Molecular Therapuetics, LLC · Jul 2007
SORBACT WOUND DRESSING
K063059 · Abigo Medical AB · Apr 2007
AQUACEL HYDROFIBER DRESSING AND AQUACEL AG WITH HYDROFIBER SILVER IMPREGNATED ANTIMICROBIAL DRESSING
K063271 · Convatec, A Division of E.R. Squibb & Sons, LLC · Apr 2007
3M TEGADERM CHG DRESSING
K063458 · 3M Company · Apr 2007