Cleared Traditional

CHESSON LABS LIQUID BANDAGE (K083913) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K083913 · Chesson Laboratory Associates, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
213d
Days
Class 1
Risk

K083913 is an FDA 510(k) clearance for the CHESSON LABS LIQUID BANDAGE. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Chesson Laboratory Associates, Inc. (Durham, US). The FDA issued a Cleared decision on July 31, 2009 after a review of 213 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 Chesson Laboratory Associates, Inc. devices

Submission Details

510(k) Number K083913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2008
Decision Date July 31, 2009
Days to Decision 213 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
98d slower than avg
Panel avg: 115d · This submission: 213d
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 K083913.
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K782008 · Abbott Laboratories · May 1979
HYDRON BURN BANDAGE MANUAL APPLICATION
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