FDA 510(k)

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

K-Number: K250586 · 2025-11-21

Decision Date2025-11-21

Product CodeOMP

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory is the device name listed in this FDA 510(k) record. The listed applicant is Deroyal Industries, Inc.. It received FDA 510(k) clearance on 2025-11-21 under 510(k) number K250586. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory?

Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory is a medical device that received FDA 510(k) clearance on 2025-11-21. The listed applicant is Deroyal Industries, Inc.. The 510(k) number is K250586.

When did Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory receive FDA 510(k) clearance?

Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory received FDA 510(k) clearance on 2025-11-21, under 510(k) number K250586.

Who is the listed applicant for Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory?

The FDA 510(k) record lists Deroyal Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory?

The FDA product code for Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory is OMP.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04042259Delayed Primary Closure Using Negative Pressure Wound TherapyACTIVE_NOT_RECRUITING NCT04618406The Effect of Negative Pressure Wound Therapy on Wound Healing in Major Amputations of the Lower LimbCOMPLETED NCT04955730NPWT in Patients Undergoing Surgical Procedures for Management of GI MalignanciesCOMPLETED NCT05598398NPWTi on Closure of Chronic Pressure SoresRECRUITING NCT05615844Antibiotic Cement Bead Pouch Versus Negative Pressure Wound TherapyRECRUITING NCT05977816PROPEL-2: Prophylactic Negative Pressure Wound Therapy in Laparotomy WoundsACTIVE_NOT_RECRUITING

Other records listing Deroyal Industries, Inc. as applicant

K230233Prospera Spectruum Negative Pressure Wound Therapy System K200631DeRoyal Temperature Monitoring Probe K200757Foley Catheter with Temperature Sensor K200319HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable K193027Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French K191425Hydro-Temp Neonatal Skin Temperature Probe Cover

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Related Devices (Code: OMP)

K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc Building K253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT Canister 500-mL (CPC-500)Cork Medical K254019Wound Geni NPWT SystemBechtel Medical, Inc.K253429Genadyne ASTRA NPWTGenadyne Biotechnologies, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.