Cleared Traditional

K133443 - MARATHON NO STING LIQUID SKIN PROTECTANT (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K133443 · Advanced Medical Solutions (Plymouth), Ltd. · General & Plastic Surgery device
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Jul 2014
Decision
240d
Days
Class 1
Risk

K133443 is an FDA 510(k) clearance for the MARATHON NO STING LIQUID SKIN PROTECTANT. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Advanced Medical Solutions (Plymouth), Ltd. (Plympton, Plymouth, Devon, GB). The FDA issued a Cleared decision on July 10, 2014 after a review of 240 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 Advanced Medical Solutions (Plymouth), Ltd. devices

Submission Details

510(k) Number K133443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2013
Decision Date July 10, 2014
Days to Decision 240 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 114d · This submission: 240d
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.