Cleared Traditional

K082703 - MRDH BANDAGE

K082703 is an FDA 510(k) clearance for MRDH BANDAGE, manufactured by Marine Polymer Technologies, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K082703 · 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
Oct 2008
Decision
28d
Days
Class 1
Risk

K082703 is an FDA 510(k) clearance for the MRDH BANDAGE. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Marine Polymer Technologies, Inc. (Danvers, US). The FDA issued a Cleared decision on October 14, 2008 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5090 - 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: 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 - K082703

510(k) Number K082703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2008
Decision Date October 14, 2008
Days to Decision 28 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
87d faster than avg
Panel avg: 115d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

KMF Device Classification - Class 1, General Controls

Product Code KMF Bandage, Liquid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5090
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KMF Bandage, Liquid

All 186
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K082703.
ECOCEL
K083087 · Polichem S.A · Aug 2009
CHESSON LABS LIQUID BANDAGE
K083913 · Chesson Laboratory Associates, Inc. · Jul 2009
GLUSEAL 90, MODEL GLU9010
K083752 · Glustitch, Inc. · Feb 2009
NEUTROPHASE
K081009 · Novabay Pharmaceuticals · May 2008
GELSPRAY WOUND DRESSING
K073663 · Biocure, Inc. · Jan 2008
PRODERMA LIQUID BANDAGE
K063202 · Procurement Technology Systems, LLC · May 2007