# K153571: Cavilon Advanced High Endurance Skin Protectant

- Pathway: 510(k) (Traditional)
- Applicant: 3M Healthcare
- Decided: Aug 23, 2016 after 252 days
- Product code: KMF (Bandage, Liquid)
- Device class: 1
- Regulation: 21 CFR 880.5090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K955103 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955103: 3M NO Sting Barrier Film, 3M Medical Products Group (1996) Summary page 4.
- K133443: Marathon NO Sting Liquid Skin Protectant, Advanced Medical Solutions (Plymouth), Ltd. (2014) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K153571
Methodology: https://510kreport.com/methodology