# K192386: KeraStat Cream

- Pathway: 510(k) (Traditional)
- Applicant: Keranetics
- Decided: Jul 16, 2020 after 317 days
- Product code: KGN (Wound Dressing With Animal-Derived Material(S))
- 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: 6 generations back to K881854 (1988). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162759: KeraStat (R) Gel, Keranetics, LLC (2017) Summary page 4.

## Indications for use
KeraStat® Cream is intended to maintain a moist wound environment. KeraStat® Cream is indicated for the management of a number of partial thickness skin wounds such as: partial thickness (first and second degree) burns, severe sunburns, superficial injuries, cuts, abrasions, and incisions/surgical wounds. Under the direction of a healthcare professional, KeraStat® Cream also may be used in the management of dry, light, and moderately exuding partial thickness wounds including: pressure (stage I-II) ulcers, venous stasis ulcers, ulcers caused by mixed vascular etiologies, diabetic ulcers, radiation dermatitis, donor sites, and grafts. KeraStat® Cream is not indicated for full thickness or third degree burns. This device will be available by prescription.

Source page: https://510kreport.com/device/K192386
Methodology: https://510kreport.com/methodology