Cleared Traditional

K991604 - EPI-FOAM SILICONE SHEETING

K991604 is an FDA 510(k) clearance for EPI-FOAM SILICONE 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 30-day FDA review.

K991604 · Biodermis Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
30d
Days
Class 1
Risk

K991604 is an FDA 510(k) clearance for the EPI-FOAM SILICONE 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 June 9, 1999 after a review of 30 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 - K991604

510(k) Number K991604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1999
Decision Date June 09, 1999
Days to Decision 30 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
85d faster than avg
Panel avg: 115d · This submission: 30d
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 K991604.
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
AVOGEL
K981353 · Avocet Polymer Technologies, Inc. · Jun 1999
NEARLY ME RETOUCH SILICONE SCAR REDUCTION SHEETS
K984213 · Capital Marketing Technologies, Inc. · Apr 1999
SCAREASE & SCAREASE ADHESIVE GEL
K984115 · Scarease, Inc. · Feb 1999