# K991061: Dermaphylyx Calcium Alginate Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Dermaphylyx, Inc.
- Decided: Jun 28, 1999 after 90 days
- Product code: NAE (Dressing, Wound, Hydrogel Without Drug And/Or Biologic)
- Device class: 1
- Regulation: 21 CFR 878.4022
- 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 its predicate without a number.
- (no number) Innovative Technologies Calcium Alginate Wound Dressings: named in the summary without a submission number
- (no number) Kaltostat® Calcium Alginate Wound Dressings: named in the summary without a submission number

## Indications for use
Dermaphylyx Calcium Alginate Wound Dressings are intended for use in the management of a variety of partial and full-thickness wounds. The dressings are additionally intended to help control minor bleeding. The following Indications are for Prescription Use or under the direction of a health carc professional: Venous uleers Diabctic ulcers Pressure ulcers Arterial ulcers Superficial burns Abrasions and lacerations Donor sites Postoperative wounds The following Indications arc for Over-the-Counter Use: Abrasions Minor Bums Minor Cuts Minor Lacerations

Source page: https://510kreport.com/device/K991061
Methodology: https://510kreport.com/methodology