Cleared Traditional

K932214 - SILON SILICONE GEL SHEET

K932214 is an FDA 510(k) clearance for SILON SILICONE GEL SHEET, 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 244-day FDA review.

K932214 · Bio Med Sciences, Inc. · General & Plastic Surgery device
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Jan 1994
Decision
244d
Days
Class 1
Risk

K932214 is an FDA 510(k) clearance for the SILON SILICONE GEL SHEET. 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 January 6, 1994 after a review of 244 days - an extended review 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: 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.

FDA 510(k) Submission Details - K932214

510(k) Number K932214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1993
Decision Date January 06, 1994
Days to Decision 244 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 115d · This submission: 244d
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 K932214.
HASKON MEDICAL GRADE SHEETING
K934829 · Haskon Intl., Inc. · Feb 1994
CICA-CARE SILICONE GEL SHEET
K935803 · Smith & Nephew United, Inc. · Feb 1994
SILICONE GEL SHEETING
K932048 · Silipos, Inc. · Jan 1994
PMT(R) SILICONE GEL SHEETING MODEL 3505-1
K930409 · Pmt Corp. · Sep 1993
SIL-K
K914701 · Degania Silicone , Ltd. · Jan 1992
SILICONE GEL SHEETING
K913140 · Cui Corp. · Sep 1991
K932214 · SILON SILICONE GEL SHEET
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