# K990438: Dermaflex Wound Dressing, Dermaflex Foam Wound Dressing, Healiaflex Wound Dressing, Healiafoam Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Dermaphylyx, Inc.
- Decided: Mar 25, 1999 after 42 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) Spyroflex® Wound Dressings: named in the summary without a submission number
- (no number) Flexzan Topical Wound Dressings: named in the summary without a submission number

## Indications for use
Dermaflex Foam Wound Dressings provide a degree of absorption and breathability. They arc 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: Venous stasis ulcers Burns, (electrical and chemical) Diabetic ulcers Abrasions and lacerations Pressure sores Incisions Donor sites Burns and abrasions associated with resurfacing procedures such as dermabrasion, chemical, and laser resurfacing Skin Tears The following indications are for Over-the-Counter Use: Abrasions Poison Ivy Sunburn Minor burns Minor cuts Minor lacerations Blisters

Source page: https://510kreport.com/device/K990438
Methodology: https://510kreport.com/methodology