Cleared Traditional

SILON(R) SILICONE THERMOPLASTIC SHEETING (K945892) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K945892 · Bio Med Sciences, Inc. · General & Plastic Surgery device
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Mar 1995
Decision
91d
Days
Class 1
Risk

K945892 is an FDA 510(k) clearance for the SILON(R) SILICONE THERMOPLASTIC SHEETING. Classified as Elastomer, Silicone, For Scar Management (product code MDA), Class I - General Controls.

Submitted by Bio Med Sciences, Inc. (Bethlehem, US). The FDA issued a Cleared decision on March 3, 1995 after a review of 91 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 Bio Med Sciences, Inc. devices

Submission Details

510(k) Number K945892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1994
Decision Date March 03, 1995
Days to Decision 91 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
24d faster than avg
Panel avg: 115d · This submission: 91d
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.