Cleared Traditional

K952546 - SILON SILICONE TEXTILE COMPOSITE

K952546 is an FDA 510(k) clearance for SILON SILICONE TEXTILE COMPOSITE, manufactured by Bio Med Sciences, Inc.. The device is a Class 1 General & Plastic Surgery device with product code MDA cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K952546 · Bio Med Sciences, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
66d
Days
Class 1
Risk

K952546 is an FDA 510(k) clearance for the SILON SILICONE TEXTILE COMPOSITE. 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 August 7, 1995 after a review of 66 days - a notably fast clearance cycle.

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: 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 Bio Med Sciences, Inc. devices

FDA 510(k) Submission Details - K952546

510(k) Number K952546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1995
Decision Date August 07, 1995
Days to Decision 66 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
49d faster than avg
Panel avg: 115d · This submission: 66d
Pathway characteristics
Predicate-based equivalence.

MDA Device Classification - Class 1, General Controls

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.

Regulatory Peers - MDA Elastomer, Silicone, For Scar Management

All 42
Devices cleared under the same product code (MDA) and FDA review panel - the closest regulatory comparables to K952546.
IMPLATECH RP MEDICAL GRADE SILICONE GEL SHEETING
K964846 · Implantech Associates, Inc. · Feb 1997
NOVAGEL SILICONE GEL SHEETING
K963128 · Brennen Medical, Inc. · Dec 1996
MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT
K962013 · Mentor Corp. · Aug 1996
SKIN NEUVEAU SCAR TREATMENT
K942339 · Puritas Health Care, Inc. · Nov 1994
SILK*SKIN SCAR TREATMENT
K941197 · Puritas Health Care, Inc. · Aug 1994
NOVAGEL SILICONE GEL SHEETING
K941125 · Brennen Medical, Inc. · May 1994