Cleared Traditional

K002488 - KELO-COTE TOPICAL GEL

K002488 is an FDA 510(k) clearance for KELO-COTE TOPICAL GEL, manufactured by Advanced Bio-Technologies, Inc.. The device is a Class 1 General & Plastic Surgery device with product code MDA cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K002488 · Advanced Bio-Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2001
Decision
144d
Days
Class 1
Risk

K002488 is an FDA 510(k) clearance for the KELO-COTE TOPICAL GEL. Classified as Elastomer, Silicone, For Scar Management (product code MDA), Class I - General Controls.

Submitted by Advanced Bio-Technologies, Inc. (Cranage, Cheshire, GB). The FDA issued a Cleared decision on January 5, 2001 after a review of 144 days - within the typical 510(k) review window.

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 - K002488

510(k) Number K002488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2000
Decision Date January 05, 2001
Days to Decision 144 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
29d slower than avg
Panel avg: 115d · This submission: 144d
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 K002488.
ACTIVHEAL SCAR MANAGEMENT DRESSING
K010245 · Advanced Medical Solutions, Ltd. · Apr 2001
MEDTRADE PRODUCTS SILICON SCAR MANAGEMENT PAD
K003979 · Medtrade Products , Ltd. · Mar 2001
EPI-DERM SILICONE GEL SHEETING
K003948 · Biodermis Corp. · Jan 2001
OLEEVA FOAM
K002109 · Bio Med Sciences, Inc. · Aug 2000
BLAINE SCARCARE PATCH
K001608 · Blaine Labs, Inc. · Jul 2000
SPECTRUM DESIGNS SPECTRAGEL
K992522 · Spectrum Designs, Inc. · Oct 1999
K002488 · KELO-COTE TOPICAL GEL
Download PDF FDA Summary Advanced Bio-Technolo…