# K210949: Foundation Dermal Regeneration Scaffold (DRS) Solo

- Pathway: 510(k) (Traditional)
- Applicant: Bionova Medical, Inc.
- Decided: Aug 11, 2022 after 499 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 K914579 (1992). 42 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123961: Sentrex Biosponge MPD, Bionova Medical, Inc. (2013) Summary page 4.

## Most influential descendants
- K231937: Foundation Dermal Regeneration Scaffold (DRS) Solo (2023), 2 descendants of its own
- K240298: Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo (2024), 1 descendant of its own
- K243181: Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo (2024), 0 descendants of its own

## Indications for use
Foundation DRS Solo 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 bums * Partial thickness bums (superficial second-degree bums) * 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 Solo may be cut to size.

Source page: https://510kreport.com/device/K210949
Methodology: https://510kreport.com/methodology