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FDA 510(k)

extriCARE® 1000 Negative Pressure Wound Therapy System

K-Number: K251646 · 2025-10-03

ApplicantAlleva Medical Devices
Decision Date2025-10-03
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

extriCARE® 1000 Negative Pressure Wound Therapy System is a medical device manufactured by Alleva Medical Devices. It received FDA 510(k) clearance on 2025-10-03 under approval number K251646. 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 extriCARE® 1000 Negative Pressure Wound Therapy System?

extriCARE® 1000 Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2025-10-03. It is manufactured by Alleva Medical Devices. The 510(k) number is K251646.

When was extriCARE® 1000 Negative Pressure Wound Therapy System approved by the FDA?

extriCARE® 1000 Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2025-10-03, under approval number K251646.

What company makes extriCARE® 1000 Negative Pressure Wound Therapy System?

extriCARE® 1000 Negative Pressure Wound Therapy System is manufactured by Alleva Medical Devices.

What is the FDA product code for extriCARE® 1000 Negative Pressure Wound Therapy System?

The FDA product code for extriCARE® 1000 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 Alleva Medical Devices

K221223extriCARE® 3000 Negative Wound Pressure Therapy System

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.

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