Prospera Spectruum Negative Pressure Wound Therapy System
K-Number: K230233 · 2024-04-18
ApplicantDeroyal Industries, Inc.
Decision Date2024-04-18
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Prospera Spectruum Negative Pressure Wound Therapy System is a medical device manufactured by Deroyal Industries, Inc.. It received FDA 510(k) clearance on 2024-04-18 under approval number K230233. 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 System?
Prospera Spectruum Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2024-04-18. It is manufactured by Deroyal Industries, Inc.. The 510(k) number is K230233.
When was Prospera Spectruum Negative Pressure Wound Therapy System approved by the FDA?
Prospera Spectruum Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2024-04-18, under approval number K230233.
What company makes Prospera Spectruum Negative Pressure Wound Therapy System?
Prospera Spectruum Negative Pressure Wound Therapy System is manufactured by Deroyal Industries, Inc..
What is the FDA product code for Prospera Spectruum Negative Pressure Wound Therapy System?
The FDA product code for Prospera Spectruum Negative Pressure Wound Therapy System is OMP.
Related Clinical Trials
NCT01143558
Searching for Persistence of Infection in Lyme Disease
COMPLETED
NCT07475091
Standardizing Swallow Pressure Measurements
NOT_YET_RECRUITING
NCT07260890
Paired Comparison of SVV and PVI Accuracy
COMPLETED
NCT06011187
Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery
COMPLETED
NCT05016219
Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients
RECRUITING
NCT07235592
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
RECRUITING
Related PubMed Literature
PMID: 41966529
Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load.
Diagnostic microbiology and infectious disease (2026)
PMID: 40942702
Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health.
Sensors (Basel, Switzerland) (2025)
PMID: 40775863
Use of the Learning Health System to Redesign and Implement a Clinical Decision Support System for Antimicrobial Stewardship.
Studies in health technology and informatics (2025)
PMID: 40624966
Peptide-Enhanced Bioactive Hydrogel Combined with Photodynamic-Phage Synergistic Antibacterial Therapy System Accelerates Infected Wound Healing.
Advanced healthcare materials (2025)
Other Devices by Deroyal Industries, Inc.
K152978DeRoyal Angiography Kits
K171475DeRoyal Laprador Specimen Retrieval System
K173072Algidex Ag Silver Alginate Wound Dressing
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
Related Devices (Code: OMP)
K160487V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) SystemKci USA, Inc.
K161128Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power SupplyMedela AG
K150960WoundPro Negative Pressure Wound Therapy SystemPensar Medical, LLC
K161935Avance Foam Dressing Kit - XLMolnlycke Health Care Us, LLC
K161948Avance Gauze Dressing KitsMolnlycke Health Care Us, LLC
K161797Avance Tubing, Avance Y-Connector, Avance ViewPadMolnlycke Health Care Us, LLC
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.