# K991608: Dermaphylyx Calcium Alginate Wound 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.
51 later devices descend from it; 2 cite it directly.
0 of 52 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) Innovative Technologies Calcium Alginate Wound Dressings (Innovative Technologies Group, Ltd.): named in the summary without a submission number
- (no number) Kaltostat® Calcium Alginate Wound Dressings (Calgon Vestal Laboratories): named in the summary without a submission number

## Most influential descendants
- K010933: Seal-on Topical Hempstatic Powder Spray (2002), 35 descendants of its own
- K024107: Femostop Femoral Compression System (2002), 23 descendants of its own
- K040730: Vascular Solutions D-Stat Clamp Hemostatic Clamp (2004), 17 descendants of its own
- K050146: Vascular Solutions D-Stat Clamp Accessory (2005), 16 descendants of its own
- K081584: Derma Sciences Otc Medihoney Dressings with Active Manuka Honey (2008), 14 descendants of its own

## Indications for use
Dermaphylyx Calcium Alginate Wound Dressings are intended for use in the management of a variety of partial and full-thickness wounds. The dressings are additionally intended to help control minot 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 Diabctic ulcers Abrasions and laccrations Pressure ulcers Donor sites Artcrial ulcers Postoperative wounds The following Indications are for Over-the-Counter Usc: Abrasions Minor Bums Minor Cuts Minor Laccrations

Source page: https://510kreport.com/device/K991608
Methodology: https://510kreport.com/methodology