# K991609: Dermaphylyx Super Absorbent Fiber Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Dermaphylyx, Inc.
- Decided: Jul 20, 1999 after 71 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 its predicate without a number.
- (no number) Aquacel™ Hydrofiber™ Wound Dressings: named in the summary without a submission number
- (no number) Kaltostat® Wound Dressings: named in the summary without a submission number

## Indications for use
Dermaphylyx Absorbent Fiber Wound Dressings are soft, non-woven, and absorptive. They 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 by application of pressure to the wound, The following Indications are for Prescription Use or under the direction of a health care professional: Venous ulcers Superficial bums Diabetic ulcers Abrasions and lacerations Pressure ulcers Donor sitcs Arterial ulcers Incisions The following Indications are for Over-the-Counter Use: Abrasions Minor Bumns Minor Cuts Minor Lacerations

Source page: https://510kreport.com/device/K991609
Methodology: https://510kreport.com/methodology