# K250586: Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory

- Pathway: 510(k) (Traditional)
- Applicant: Deroyal Industries, Inc.
- Decided: Nov 21, 2025 after 267 days
- Product code: OMP (Negative Pressure Wound Therapy Powered Suction Pump)
- Device class: 2
- Regulation: 21 CFR 878.4780
- 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 K100821 (2010). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133276: V.a.C. Granufoam Dressing, Granufoam Thin Dressing, Granufoam Round Dressing, Granufoam Silver Dressing, Whitefoam Dress, Kci USA, Inc. (2013) Summary page 5.
- K213853: RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large, Smith and Nephew Medical Limited (2023) Summary page 5.

## Indications for use
The Prospera Spectruum™ Negative Pressure Wound Therapy System is a wound management system intended for use in acute, extended and home care settings. When used on open wounds, it is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts. When used on closed surgical incisions, it is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

Source page: https://510kreport.com/device/K250586
Methodology: https://510kreport.com/methodology