Cleared Traditional

K951561 - DYNASORB

K951561 is an FDA 510(k) clearance for DYNASORB, manufactured by Dermarx Corp.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K951561 · Dermarx Corp. · General & Plastic Surgery device
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Sep 1995
Decision
149d
Days
Class 1
Risk

K951561 is an FDA 510(k) clearance for the DYNASORB. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Dermarx Corp. (Denver, US). The FDA issued a Cleared decision on September 1, 1995 after a review of 149 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 Dermarx Corp. devices

FDA 510(k) Submission Details - K951561

510(k) Number K951561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1995
Decision Date September 01, 1995
Days to Decision 149 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
34d slower than avg
Panel avg: 115d · This submission: 149d
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 108
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K951561.
COMFEEL:ALGINATE DRESSING
K953497 · Coloplast A/S · Sep 1995
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