# K023136: Oleeva Fabric

- Pathway: 510(k) (Special)
- Applicant: Bio Med Sciences, Inc.
- Decided: Oct 16, 2002 after 26 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: 2 generations back to K932214 (1994). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
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.
- K002109: Oleeva Foam, Bio Med Sciences, Inc. (2000) Summary page 1.

## Most influential descendants
- K024160: Neosporin Scar Solution (2003), 0 descendants of its own

## Indications for use
Oleeva Fabric is indicated for the management of hypertrophic scars and keloids. Consistent use of Oleeva Fabric can reduce hypertrophic scaring and keloid formation resulting from surgical or traumatic injury of the skin. Oleeva Fabric 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/K023136
Methodology: https://510kreport.com/methodology