# K042352: Bioderm Sciences Wound Cream

- Pathway: 510(k) (Traditional)
- Applicant: Bioderm Sciences, Inc.
- Decided: Oct 17, 2005 after 413 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K945802 (1995). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040683: Bioderm Sciences Wound Dressing, Bioderm Sciences, Inc. (2004) Summary page 1.
- K042084: Bioderm Sciences Wound Healing Spray, Bioderm Sciences, Inc. (2005). Cleared while this submission was under review Summary page 1.
- K970660: Dermagran Wound Management System, Derma Sciences, Inc. (1997) Summary page 1.

## Most influential descendants
- K063805: Silcryst Silver Antimicrobial Wound Cream, Model a-00901 (2007), 0 descendants of its own

## Indications for use
BioDerm Sciences Wound Cream is intended to externally manage derral lesions such as lacerations, post-operative (surgical) wounds, partial and full-thickness wounds, I " and 2a degree bums and ulcers (diabetic, venous stasis, pressure). It may also be used in conjunction with a dressing that absorbs fluids (i.e. gauze, gel, alginate, foam, hydrocolloid).

Source page: https://510kreport.com/device/K042352
Methodology: https://510kreport.com/methodology