# K003948: Epi-Derm Silicone Gel Sheeting

- Pathway: 510(k) (Traditional)
- Applicant: Biodermis Corp.
- Decided: Jan 29, 2001 after 39 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K112131: Neodyne Dressing (2011), 0 descendants of its own
- K111733: Coreleader Scar-Dimmer (2011), 0 descendants of its own

Source page: https://510kreport.com/device/K003948
Methodology: https://510kreport.com/methodology