Cleared Traditional

MEPORE (6X7) (K954274) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K954274 · Scott Health Care · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1995
Decision
97d
Days
Class 1
Risk

K954274 is an FDA 510(k) clearance for the MEPORE (6X7). Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Scott Health Care (Fort Worth, US). The FDA issued a Cleared decision on December 19, 1995 after a review of 97 days - within the typical 510(k) review window.

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: 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 Scott Health Care devices

Submission Details

510(k) Number K954274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1995
Decision Date December 19, 1995
Days to Decision 97 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
18d faster than avg
Panel avg: 115d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 221
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K954274.
TearRepair Liquid Skin Protectant
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Aleo BME Liquid Bandage
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3M LIQUID BANDAGE
K053409 · 3M Company · Jun 2006
3M LIQUID BANDAGE, MODEL 120-LB
K031263 · 3M Company · Oct 2003
ALGISITE M
K983210 · Smith & Nephew, Inc. · Dec 1998