Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory
FDA 510(k) K250586 · Deroyal Industries, Inc.
Submission
- Device name
- Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory
- Applicant
- Deroyal Industries, Inc.
Powell, TN, US - Received
- February 27, 2025
- Decision date
- November 21, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OMP – Negative Pressure Wound Therapy Powered Suction Pump
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4780
- Specialty
- General, Plastic Surgery
For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The Device is indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
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|---|---|---|---|
| K261338 | RENASYS DYNAFLOW Kit (66807741)OMP · Traditional | Smith & Nephew Medical, Ltd. | 09/11/2026SE |
| K253263 | ConvaVAC Negative Pressure Wound Therapy SystemOMP · Traditional | Convatec Limited, Gdc Building | 06/24/2026SE |
| K253199 | Curasys 2 (EMDN0003)OMP · Traditional | CG Bio Co., Ltd. | 06/23/2026SE |
| K260646 | Renasys Edge (66803126)OMP · Traditional | Smith & Nephew Medical, Ltd. | 05/27/2026SE |
| K261291 | Nisus NPWT Canister 500-mL (CPC-500)OMP · Special | Cork Medical | 05/21/2026SE |
| K254019 | Wound Geni NPWT SystemOMP · Traditional | Bechtel Medical, Inc. | 05/04/2026SE |
| K253429 | Genadyne ASTRA NPWTOMP · Traditional | Genadyne Biotechnologies, Inc. | 03/12/2026SE |
| K251646 | extriCARE® 1000 Negative Pressure Wound Therapy SystemOMP · Traditional | Alleva Medical Devices | 10/03/2025SE |
| K251826 | RENASYS WOUND+ Dressing Kit with AIRLOCK TechnologyOMP · Traditional | Smith & Nephew Medical, Ltd. | 09/11/2025SE |
| K243187 | Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)OMP · Traditional | Cork Medical | 06/27/2025SE |
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| K230233 | Prospera Spectruum Negative Pressure Wound Therapy SystemOMP · Traditional | 04/18/2024SE |
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| K191425 | Hydro-Temp Neonatal Skin Temperature Probe CoverFMT · Traditional | 01/21/2020SE |
| K173072 | Algidex Ag Silver Alginate Wound DressingFRO · Traditional | 04/04/2018SE |
| K171475 | DeRoyal Laprador Specimen Retrieval SystemGCJ · Traditional | 08/17/2017SE |
| K152978 | DeRoyal Angiography KitsDXT · Traditional | 03/25/2016SESK |
| K142962 | PROTOCOL Incision DressingFRO · Traditional | 07/23/2015SE |
Questions and answers
When was Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory cleared by the FDA?
Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory (K250586) received a 510(k) decision of Substantially Equivalent on November 21, 2025, 267 days after the submission was received.
What is the product code of K250586?
The FDA product code is OMP – Negative Pressure Wound Therapy Powered Suction Pump, a Class II (moderate risk) device regulated under 21 CFR 878.4780.