# K982778: Bioderm Foam Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Bioderm, Inc.
- Decided: Oct 21, 1998 after 75 days
- Product code: KMF (Bandage, Liquid)
- Device class: 1
- Regulation: 21 CFR 880.5090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Bioderm, Inc. foam dressing is an external wound dressing designed to help maintain a moist wound healing environment and manage exudate. The dressing is indicated for the local management of the following types of wounds: 1. Partial and full thickness wounds, moderate to heavily exudating wounds such as; a. venous stasis ulcers. b. pressure sores. c. post operative incisions. d. diabetic ulcers. 2. Partial thickness wounds such as; a. abrasions. b. lacerations. c. donor sites. d. superficial burns. 3. Other indications include; a. drainage dressing for tracheostomy and gastrostomy tubs.

Source page: https://510kreport.com/device/K982778
Methodology: https://510kreport.com/methodology