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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 79
Devices cleared under the same product code (MDA) and FDA review panel - the closest regulatory comparables to K952546.
KELOCOTE
K954413 · Allied Biomedical Corp. · Nov 1995
DURASIL
K952612 · The S. F. Group, Inc. · Nov 1995
SILK*SKIN SCAR TREATMENT
K953420 · Silk*Skin Care Co. · Sep 1995
SILON SILICONE FOAM SHEETING
K946362 · Bio Med Sciences, Inc. · Jul 1995
SILON(R) SILICONE THERMOPLASTIC SHEETING
K945892 · Bio Med Sciences, Inc. · Mar 1995
SKIN NEUVEAU SCAR TREATMENT
K942339 · Puritas Health Care, Inc. · Nov 1994
K952546 · SILON SILICONE TEXTILE COMPOSITE
Download PDF FDA Summary Bio Med Sciences, Inc.