Cleared Traditional

K952547 - COVERSAN, ISLESAN

K952547 is an FDA 510(k) clearance for COVERSAN, manufactured by Medical Device Development Co.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K952547 · Medical Device Development Co. · General & Plastic Surgery device
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Aug 1995
Decision
73d
Days
Class 1
Risk

K952547 is an FDA 510(k) clearance for the COVERSAN, ISLESAN. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Medical Device Development Co. (Morris Plains, US). The FDA issued a Cleared decision on August 14, 1995 after a review of 73 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.

View all Medical Device Development Co. devices

FDA 510(k) Submission Details - K952547

510(k) Number K952547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1995
Decision Date August 14, 1995
Days to Decision 73 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 115d · This submission: 73d
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 157
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K952547.
HYDROPHILIC FOAM DRESSING
K953019 · Busse Hospital Disposables, Inc. · Sep 1995
WOUNDFOAM 4 X 4
K953070 · Trinity Laboratories, Inc. · Sep 1995
CUTINOVA CAVITY
K952526 · Beiersdorf, Inc. · Aug 1995
SPYROFOAM WOUND DRESSING
K951730 · Polymedica Industries, Inc. · Jun 1995
DERMAGRAN HYDROPHILIC OINTMENT
K951499 · Derma Sciences, Inc. · Apr 1995
CURASORB ZN ALGINATE WOUND DRESSING
K950775 · Kendall Healthcare Products Co. Div.Of Tyco Health · Apr 1995