510(k) · Cleared
ClearedCavilon Advanced High Endurance Skin Protectant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Healthcare · KMF Bandage, Liquid
Cleared on Aug 23, 2016 as substantially equivalent to K955103 (3M Medical Products Group, 1996) and 1 other predicate after a 252-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Aug 23, 2016
- Review
- 252 days
- Class
- Class I
- Product code
- KMF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K955103 (1996). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK955103 3M NO Sting Barrier Film3M Medical Products Group · 1996
- This deviceK153571 Cavilon Advanced High Endurance Skin Protectant3M Healthcare · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955103 | 3M NO Sting Barrier Film | 3M Medical Products Group | 1996 | — |
| 0 (this device) | K153571 | Cavilon Advanced High Endurance Skin Protectant | 3M Healthcare | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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 K241916 TearRepair Liquid Skin Protectantscore 8.1 · 1 generation · no Class I recall
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K955103 | 3M NO Sting Barrier FilmSummary page 4…Regulatory Class: Class 1 Product Code: KMF per 21 CFR 880.5090 III. PREDICATE DEVICE 3M™ Cavilon™ No Sting Barrier Film (K955103) Medline® Marathon® Liquid Skin Protectant (K133443) IV. DEVICE DESCRIPTION 3M™ Cavilon™ Advanced Skin Protec… | 1996 |
| * | K133443 | Marathon NO Sting Liquid Skin ProtectantSummary page 4…: KMF per 21 CFR 880.5090 III. PREDICATE DEVICE 3M™ Cavilon™ No Sting Barrier Film (K955103) Medline® Marathon® Liquid Skin Protectant (K133443) IV. DEVICE DESCRIPTION 3M™ Cavilon™ Advanced Skin Protectant is a polymeric-cyanoacrylate solution intended… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
- 4 other devices also cite its predicate K955103.
How does its category compare?
All KMF devicesKMF Bandage, Liquid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · KMF
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · KMF
213in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KMF
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KMF
12in 2025
MAUDE reports naming product code KMF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 1 | 6 |
| 2008 | 3 | 35 | 0 | 2 |
| 2009 | 3 | 213 | 0 | 6 |
| 2010 | 1 | — | 0 | 7 |
| 2011 | 0 | — | 1 | 16 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 34 |
| 2014 | 2 | — | 0 | 24 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 2 | — | 0 | 18 |
| 2017 | 0 | — | 0 | 16 |
| 2018 | 1 | — | 0 | 10 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 1 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 12 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Cavilon™ Advanced Skin Protectant forms a film barrier intended to protect intact or damaged skin. It is effective in conditions where skin is frequently or continuously exposed to moisture and caustic irritants such as feces, digestive fluids, wound drainage and urine. Cavilon™ Advanced Skin Protectant also can be used in areas exposed to friction and shear from bedding, clothing, shoes or any other material that would rub against the skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153571 · printed Nov 4, 2026
Cite this page
510(k) Report. “K153571: Cavilon Advanced High Endurance Skin Protectant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K153571
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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