# K241904: DermiSphere Dermal Template

- Pathway: 510(k) (Traditional)
- Applicant: Fesariustherapeutics, Inc.
- Decided: Jan 6, 2025 after 189 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: 4 generations back to K881854 (1988). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022127: Avagen Wound Dressing, Integra Lifesciences Corp. (2002) Summary page 5.

## Indications for use
DermiSphere™ hDRT hydrogel Dermal Regeneration Template is a wound dressing indicated for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post Moh’s surgery, post laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second degree burns, skin tears) and draining wounds. This device is intended for one-time use.

Source page: https://510kreport.com/device/K241904
Methodology: https://510kreport.com/methodology