# K990891: Dermaphylyx Hydrocolloid Wound Dressing, Healian Hydrocolloid Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Dermaphylyx, Inc.
- Decided: May 27, 1999 after 71 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
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) SpyroColloid® Wound Dressings: named in the summary without a submission number

## Indications for use
Dermaphylyx Hydrocolloid Wound Drossings are self-adhesive and semi-occlusive. They are intended for use in the management of a variety of partial and full-thickness wounds. The following Indications are for Preseription Use or under the dircotion of a health carc profcssional: Venous stasis ulcers Superficial bums Diabetiv uleeas Abrasions and laccrations Pressure sores Donor sites Blisters The following Indications are for Over-the-Counter Use: Abrasions Minor Burns Minor Cuts Minor Lacerations Blisters

Source page: https://510kreport.com/device/K990891
Methodology: https://510kreport.com/methodology