# K024160: Neosporin Scar Solution

- Pathway: 510(k) (Traditional)
- Applicant: Warner-Lambert Co.
- Decided: Mar 17, 2003 after 90 days
- Product code: MDA (Elastomer, Silicone, For Scar Management)
- Device class: 1
- Regulation: 21 CFR 878.4025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K932214 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982036: Silon Scar Strips, Bio Med Sciences, Inc. (1998) Summary page 1.
- K023136: Oleeva Fabric, Bio Med Sciences, Inc. (2002)

## Indications for use
[Trade Name] silicone sheeting is indicated for management of hypertrophic scars and keloids. Consistent use of [Trade Name] can reduce hypertrophic scarring and keloid formation, resulting from surgical or traumatic injury of the skin. [Trade Name] may be useful as a prophylaxis after surgical or traumatic dermal injury to aid in the prevention of hypertrophic scars and keloids.

Source page: https://510kreport.com/device/K024160
Methodology: https://510kreport.com/methodology