Cleared Traditional

K953500 - HEMO-BARRIER

K953500 is an FDA 510(k) clearance for HEMO-BARRIER, manufactured by Asia Dynamics, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K953500 · Asia Dynamics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Jan 1996
Decision
182d
Days
Class 1
Risk

K953500 is an FDA 510(k) clearance for the HEMO-BARRIER. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Asia Dynamics, Inc. (Niles, US). The FDA issued a Cleared decision on January 24, 1996 after a review of 182 days - an extended review 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: 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 Asia Dynamics, Inc. devices

FDA 510(k) Submission Details - K953500

510(k) Number K953500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1995
Decision Date January 24, 1996
Days to Decision 182 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
67d slower than avg
Panel avg: 115d · This submission: 182d
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 75
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K953500.
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LYOFOAM EXTRA
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COMFEEL:ALGINATE FILLER
K954857 · Coloplast Corp. · Nov 1995
DEROYAL INDUSTRIES, INC. POLYDERM & POLYDERM BORDER FOAM WOUND DRESSINGS
K953403 · Deroyal Industries, Inc. · Oct 1995