# K210135: PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing

- Pathway: 510(k) (Traditional)
- Applicant: 3M Healthcare Business Group
- Decided: Feb 24, 2022 after 401 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: 5 generations back to K881854 (1988). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081635: Integra Meshed Bilayer Wound Matrix, Integra Lifesciences Corp. (2008) Summary page 7.

## Most influential descendants
- K251999: Promogran Prisma™ Collagen Matrix with ORC and Silver (2026), 0 descendants of its own

## Indications for use
Promogran Prisma™, when used without ActiV.A.C.™ Negative Pressure Wound Therapy, is intended for the management of exuding wounds. Under the supervision of a health care professional, Promogran Prisma™ may be used for the management of: • Diabetic ulcers • Venous ulcers • Pressure ulcers • Ulcers caused by mixed vascular etiologies • Full-thickness & partial thickness wounds • Donor sites and other bleeding surface wounds • Abrasions • Traumatic wounds healing by secondary intention • Dehisced surgical wounds. Promogran Prisma™ when used with ActiV.A.C.™ Negative Pressure Wound Therapy is intended for the management of exuding wounds. Under the supervision of a health care professional, Promogran Prisma™ with ActiV.A.C.™ Negative Pressure Wound Therapy may be used only for the management of: • Diabetic ulcers • Venous ulcers • Pressure ulcers • Partial-thickness burns • Traumatic wounds healing by secondary intention • Dehisced surgical wounds. Compression therapy may only be used with Promogran Prisma™ under professional healthcare supervision. Compression therapy may not be used when Promogran Prisma™ is used with ActiV.A.C.™ Negative Pressure Wound Therapy.

Source page: https://510kreport.com/device/K210135
Methodology: https://510kreport.com/methodology