# K080949: Keratec Wound Dressings

- Pathway: 510(k) (Traditional)
- Applicant: Keratec Limited
- Decided: Feb 11, 2009 after 314 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K881854 (1988). 15 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061711: Oasis Wound Matrix, Cook Biotech, Inc. (2006) Summary page 1.
- K022995: Collatek Hydrogel, Biocore Medical Technologies, Inc. (2002) Summary page 1.
- K012997: Collatek Foam, Biocore Medical Technologies, Inc. (2001)
- K033523: Collagen-Orc Antimicrobial Matrix, Johnson & Johnson Medical, Ltd. (2004) Summary page 1.

## Most influential descendants
- K162759: KeraStat (R) Gel (2017), 1 descendant of its own
- K192386: KeraStat Cream (2020), 0 descendants of its own
- K182010: ProgenaMatrix (2019), 0 descendants of its own

## Indications for use
The Keratec Keragel, Kerafoam and Keraderm Wound Dressings are intended for the management of partial and full thickness wounds such as: · first and second degree burns * severe sunburns * superficial injuries, cuts, abrasions and surgical wounds The Keratec Wound Dressings may also be used under guidance of a health care professional in the management of the following types of dry, light and moderately exudating partial and full thickness wounds: * Pressure (stage I-IV) and venous stasis ulcers · Ulcers caused by mixed vascular etiologies · Diabetic ulcers * Donor sites and grafts Keragel is intended for dry to moderately exuding wounds, Keraderm for low to highly exuding wounds and Kerafoam for moderately exuding wounds to highly exuding wounds. The Keratec Wound Dressings are not intended to be used on third degree burns.

Source page: https://510kreport.com/device/K080949
Methodology: https://510kreport.com/methodology