Cleared Traditional

K010245 - ACTIVHEAL SCAR MANAGEMENT DRESSING (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K010245 · Advanced Medical Solutions, Ltd. · General & Plastic Surgery device
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Apr 2001
Decision
90d
Days
Class 1
Risk

K010245 is an FDA 510(k) clearance for the ACTIVHEAL SCAR MANAGEMENT DRESSING. Classified as Elastomer, Silicone, For Scar Management (product code MDA), Class I - General Controls.

Submitted by Advanced Medical Solutions, Ltd. (Winsford, Cheshire, GB). The FDA issued a Cleared decision on April 25, 2001 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4025 - 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 Advanced Medical Solutions, Ltd. devices

Submission Details

510(k) Number K010245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2001
Decision Date April 25, 2001
Days to Decision 90 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
24d faster than avg
Panel avg: 114d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MDA Elastomer, Silicone, For Scar Management
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4025
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.