# K974143: KMC Newskin

- Pathway: 510(k) (Traditional)
- Applicant: Kmc Intl. Co.
- Decided: Mar 27, 1998 after 144 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: 1 generation back to K971482 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971482: Degania Silicone Sil-K, Degania Silicone, Ltd. (1997) Summary page 1.

## Indications for use
KMC Ultra-Sil Scar Management System is a thin, soft silicone sheet designed for non-invasive application for keloid and hypertrophic scar management. KMC Ultra-Sil Scar Management System is intended to be used only on healed scars.

Source page: https://510kreport.com/device/K974143
Methodology: https://510kreport.com/methodology