Cleared Traditional

K992146 - SCARAID SILICONE GEL SHEETING

K992146 is an FDA 510(k) clearance for SCARAID SILICONE GEL SHEETING, manufactured by Biodermis Corp.. The device is a Class 1 General & Plastic Surgery device with product code MDA cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K992146 · Biodermis Corp. · General & Plastic Surgery device
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Jul 1999
Decision
36d
Days
Class 1
Risk

K992146 is an FDA 510(k) clearance for the SCARAID SILICONE GEL SHEETING. Classified as Elastomer, Silicone, For Scar Management (product code MDA), Class I - General Controls.

Submitted by Biodermis Corp. (Las Vegas, US). The FDA issued a Cleared decision on July 30, 1999 after a review of 36 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 Biodermis Corp. devices

FDA 510(k) Submission Details - K992146

510(k) Number K992146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1999
Decision Date July 30, 1999
Days to Decision 36 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
79d faster than avg
Panel avg: 115d · This submission: 36d
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 51
Devices cleared under the same product code (MDA) and FDA review panel - the closest regulatory comparables to K992146.
SKIN 2 FORTE SILICONE SHEETING
K990651 · United Hospital Technologies, Inc. · Aug 1999
SILGEL STC-S
K984029 · Nagor , Ltd. · Aug 1999
CICACARE ROLL-ON GEL-SCAR MANAGEMENT LIQUID GEL.
K991968 · Smith & Nephew, Inc. · Jul 1999
CICACARE MANAGEMENT FOR SCARS
K991957 · Smith & Nephew, Inc. · Jul 1999
TENDER TOUCH SILICONE GEL PADS
K991478 · Capital Marketing Technologies, Inc. · Jun 1999
ADVANCED MEDICAL SOLUTIONS-SILICONE GEL SCAR MANAGEMENT SHEET
K991630 · Advanced Medical Solutions Group Plc · Jun 1999