# K112131: Neodyne Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Neodyne Biosciences, Inc.
- Decided: Sep 29, 2011 after 65 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 K813265 (1983). 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)
- K003948: Epi-Derm Silicone Gel Sheeting, Biodermis Corp. (2001) Summary page 1.
- K813265: 3M Steri-Strip Antimicrobial Skin Clos, 3M Company (1983) Summary page 1.

## Indications for use
The Neodyne Dressing is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.

Source page: https://510kreport.com/device/K112131
Methodology: https://510kreport.com/methodology