510(k) Report

510(k) · Cleared

Cleared

Marathon NO Sting Liquid Skin Protectant

K133443510(k) TraditionalCleared Jul 10, 2014240-day reviewClass I21 CFR 880.5090

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Advanced Medical Solutions (Plymouth), Ltd. · KMF Bandage, Liquid

Cleared on Jul 10, 2014 after a 240-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.

Decided
Jul 10, 2014
Review
240 days
Class
Class I
Product code
KMF
Recalls
None
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2016: 1 descendant cleared2024: 1 descendant cleared2010201520202025
  1. This deviceK133443 Marathon NO Sting Liquid Skin ProtectantAdvanced Medical Solutions (Plymouth), Ltd. · 2014
  2. Descendant · cites it directly · 0 of its ownK241916 TearRepair Liquid Skin ProtectantOptmed, Inc. · 2024
  3. Descendant · cites it directly · 0 of its ownK153571 Cavilon Advanced High Endurance Skin Protectant3M Healthcare · 2016

Most influential descendants

Showing 2 of 2 · See all
  • K241916TearRepair Liquid Skin ProtectantOptmed, Inc. · 2024 · cites it directly0descendants
  • K153571Cavilon Advanced High Endurance Skin Protectant3M Healthcare · 2016 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K133443Marathon NO Sting Liquid Skin ProtectantAdvanced Medical Solutions (Plymouth), Ltd.2014—
+1K241916TearRepair Liquid Skin ProtectantOptmed, Inc.2024—
+1K153571Cavilon Advanced High Endurance Skin Protectant3M Healthcare2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
202410
FIG. 1 — Lineage of K133443, 2014–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KMF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KMF device

  1. #1 K241916 TearRepair Liquid Skin Protectantscore 8.1 · 1 generation · no Class I recall
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K241916TearRepair Liquid Skin ProtectantOptmed, Inc.20240
K153571Cavilon Advanced High Endurance Skin Protectant3M Healthcare20160

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K241916 (Optmed, Inc., 2024) has gone furthest, with 0 descendants of its own.

How does its category compare?

All KMF devices

KMF Bandage, Liquid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · KMF

1in 2024

2007: 22008: 32009: 32010: 12012: 12014: 22016: 22018: 12019: 12024: 1
2007high 3 (2008) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KMF

213in 2009

2008: 35 days median2009: 213 days median
2007high 213 (2009) · low 35 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KMF

1in 2011

2007: 12011: 1
2007high 1 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KMF

12in 2025

2007: 62008: 22009: 62010: 72011: 162012: 32013: 342014: 242015: 132016: 182017: 162018: 102019: 62020: 82021: 102022: 72023: 62024: 62025: 12
2007high 34 (2013) · low 2 (2008)2025

MAUDE reports naming product code KMF, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—16
200833502
2009321306
20101—07
20110—116
20121—03
20130—034
20142—024
20150—013
20162—018
20170—016
20181—010
20191—06
20200—08
20210—010
20220—07
20230—06
20241—06
20250—012
20260—0—

What is it indicated for?

Marathon No Sting Liquid Skin Protectant helps protect skin exposed to Irritation from moisture such as urine, faeces, digestive juices, perspiration and wound drainage. Marathon No Sting Liquid Skin Protectant can also be used in areas that are exposed to friction and shear from bedding, clothing, shoes, or any material that will rub against the skin. Marathon No Sting Liquid Skin Protectant helps protect the skin against Irritation caused by adhesive products.

Indications for use as stated in the FDA 510(k) statement.

Cite this page

510(k) Report. “K133443: Marathon NO Sting Liquid Skin Protectant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133443

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026