Cleared Traditional

PRODERMA LIQUID BANDAGE (K063202) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K063202 · Procurement Technology Systems, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
194d
Days
Class 1
Risk

K063202 is an FDA 510(k) clearance for the PRODERMA LIQUID BANDAGE. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Procurement Technology Systems, LLC (Greer, US). The FDA issued a Cleared decision on May 2, 2007 after a review of 194 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5090 - 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.

View all Procurement Technology Systems, LLC devices

Submission Details

510(k) Number K063202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2006
Decision Date May 02, 2007
Days to Decision 194 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 115d · This submission: 194d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMF Bandage, Liquid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5090
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 - KMF Bandage, Liquid

All 221
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K063202.
TearRepair Liquid Skin Protectant
K241916 · Optmed, Inc. · Sep 2024
Rochal Bioshield Silicone Film
K182733 · Rochal Industries, LLC · Jun 2019
Aleo BME Liquid Bandage
K171148 · Aleo Bme, Inc. · Jan 2018
3M LIQUID BANDAGE
K053409 · 3M Company · Jun 2006
3M LIQUID BANDAGE, MODEL 120-LB
K031263 · 3M Company · Oct 2003
ALGISITE M
K983210 · Smith & Nephew, Inc. · Dec 1998