# K990875: Dermaphylyx Film Wound Dressing and Healian Film Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Dermaphylyx, Inc.
- Decided: May 27, 1999 after 72 days
- Product code: MGP (Dressing, Wound And Burn, Occlusive)
- 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) SpyroFilm® (aka SpyroDerm®): named in the summary without a submission number
- (no number) Mitrasheer™ Wound Dressings: named in the summary without a submission number

## Indications for use
Dermaphylyx Film Wound Dressings 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 Prescription Use or under the direction of a health care professional: Dermal Ulcers Superficial Burns Donor Sites Abrasions and lacerations Incisions IV Catheter Sites The following Indications are for Over-the-Counter Use: Abrasions Minor Burns Minor Cuts Minor Lacerations Blisters As a Cover for gauze and gel bandages.

Source page: https://510kreport.com/device/K990875
Methodology: https://510kreport.com/methodology