Cleared Traditional

K133443 - MARATHON NO STING LIQUID SKIN PROTECTANT

K133443 is an FDA 510(k) clearance for MARATHON NO STING LIQUID SKIN PROTECTANT, manufactured by Advanced Medical Solutions (Plymouth), Ltd.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 240-day FDA review.

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

FDA 510(k) Submission Details - K133443

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
125d slower than avg
Panel avg: 115d · This submission: 240d
Pathway characteristics
Predicate-based equivalence.

KMF Device Classification - Class 1, General Controls

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 92
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K133443.
Rochal Bioshield Silicone Film
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Aleo BME Liquid Bandage
K171148 · Aleo Bme, Inc. · Jan 2018
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K153571 · 3M Healthcare · Aug 2016
3M LIQUID BANDAGE
K053409 · 3M Company · Jun 2006
MEDTRADE PRODUCTS SKIN PROTECTIVE BARRIER WIPE (STERILE AND PRESERVED)
K051082 · Medtrade Products , Ltd. · Nov 2005
RESTORE WOUND CLEANSER
K040779 · Hollister, Inc. · May 2004