Cleared Traditional

K954413 - KELOCOTE

K954413 is an FDA 510(k) clearance for KELOCOTE, manufactured by Allied Biomedical Corp.. The device is a Class 1 General & Plastic Surgery device with product code MDA cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K954413 · Allied Biomedical Corp. · General & Plastic Surgery device
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Nov 1995
Decision
69d
Days
Class 1
Risk

K954413 is an FDA 510(k) clearance for the KELOCOTE. Classified as Elastomer, Silicone, For Scar Management (product code MDA), Class I - General Controls.

Submitted by Allied Biomedical Corp. (Paso Robles, US). The FDA issued a Cleared decision on November 29, 1995 after a review of 69 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 - K954413

510(k) Number K954413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1995
Decision Date November 29, 1995
Days to Decision 69 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
46d faster than avg
Panel avg: 115d · This submission: 69d
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 K954413.
MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT
K962013 · Mentor Corp. · Aug 1996
SILGEL TOPICAL GEL SHEET
K960254 · Rofil Medical USA, Inc. · Apr 1996
STERILIZED TRI BLOCK POLYMER GEL SHEET
K955664 · Silipos, Inc. · Feb 1996
DURASIL
K952612 · The S. F. Group, Inc. · Nov 1995
SILK*SKIN SCAR TREATMENT
K953420 · Silk*Skin Care Co. · Sep 1995
SILON SILICONE TEXTILE COMPOSITE
K952546 · Bio Med Sciences, Inc. · Aug 1995
K954413 · KELOCOTE
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