# K991920: Dermaphylyx Hydrophilic Foam Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Dermaphylyx, Inc.
- Decided: Aug 12, 1999 after 66 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices 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) Spyrofoam® Wound Dressings (Innovative Technologies US, Inc.): named in the summary without a submission number
- (no number) Hydrasorb® Sterile Dressings (ConvaTec/Calgon Vestal Laboratories): named in the summary without a submission number

## Most influential descendants
- K131384: Kericure Advanced Liquid Bandage, Natural Seal Liquid Bandage, Liquid Bandage (2014), 2 descendants of its own
- K182733: Rochal Bioshield Silicone Film (2019), 0 descendants of its own
- K171148: Aleo BME Liquid Bandage (2018), 0 descendants of its own

## Indications for use
Dermaphylyx Hydrophilic Foam Dressing Foam Wound Dressings provide a degree of exudate absorption. They are intended for use in the management of partial and full-thickness wounds. The following indications for use are for Prescription Use or under the direction of a health care professional: Venous stasis ulcers Burns, (superficial) Diabetic ulcers Abrasions and lacerations Pressure sores Incisions Donor sites Additionally Fenestrated dressings are intended for use in the management of surgically induced drainage sites such as: G-tubes, J-tubes, Penrose drains, chest tubes, nephrotomy tubes, and sump drains. The following indications for use are for Over-the-Counter Use: Minor Burns Minor cuts Minor abrasions Minor lacerations

Source page: https://510kreport.com/device/K991920
Methodology: https://510kreport.com/methodology