# K980451: Bioderm Calcium Alginate Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Bioderm, Inc.
- Decided: Apr 9, 1998 after 63 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. The FDA summary names no predicate by number.

## Indications for use
1. Venous Stasis Ulcers 2. Pressure Ulcers 3. Diabetic Ulcers 4. Surgical Wounds

Source page: https://510kreport.com/device/K980451
Methodology: https://510kreport.com/methodology