# K240298: Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo

- Pathway: 510(k) (Traditional)
- Applicant: Bionova Medical, Inc.
- Decided: Aug 21, 2024 after 202 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: 9 generations back to K973688 (1997). 77 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231937: Foundation Dermal Regeneration Scaffold (DRS) Solo, Bionova Medical, Inc. (2023) Summary page 5.

## Most influential descendants
- K243181: Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo (2024), 0 descendants of its own

## Indications for use
Foundation DRS+ Duo is indicated for the management of wounds including: • Full thickness and partial thickness wounds • Pressure ulcers • Venous ulcers • Ulcers caused by mixed vascular etiologies • Diabetic ulcers • First degree burns • Partial thickness burns (superficial second-degree burns) • Donor sites and other bleeding surface wounds • Abrasions • Trauma wounds (abrasions, lacerations, skin tears) • Dehisced wounds • Surgical wounds (donor sites/grafts, post-Moh’s surgery, post-laser surgery, podiatric, wound dehiscence) Foundation DRS+ Duo may be cut to size.

Source page: https://510kreport.com/device/K240298
Methodology: https://510kreport.com/methodology