# K250397: Helios Dermal Scaffold

- Pathway: 510(k) (Traditional)
- Applicant: Helios Biomedical, Inc.
- Decided: Aug 15, 2025 after 184 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: 8 generations back to K881854 (1988). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153690: PriMatrix Dermal Repair Scaffold, Tei Biosciences, Inc. (2016) Summary page 5.

## Indications for use
Helios Dermal Scaffold is intended for the management of wounds that include: Partial- and full- thickness wounds Pressure, diabetic, and venous ulcers Partial thickness burns Surgical wounds — donor sites/grafts, post-Moh’s surgery, post-laser surgery, podiatric, wound dehiscence Trauma wounds — abrasions, lacerations and skin tears Tunneled/undermined wounds Draining wounds

Source page: https://510kreport.com/device/K250397
Methodology: https://510kreport.com/methodology