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NPD 1000 Negative Pressure Wound Therapy System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K080275

by Iasis Medical, Inc.

Identifiers

510(k) Number
K080275 FDA 510(k)
FDA Product Code
OMP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4780 FDA 510(k)
Regulation Number
878.4780 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The NPD 1000 Negative Pressure Wound Therapy System is a powered suction pump designed for negative pressure wound therapy. It applies controlled suction to wound beds to remove exudate and infectious material, promoting wound healing by enhancing granulation tissue formation and reducing bacterial load. This device is classified as a Class II medical device under FDA regulation 878.4780, specifically as a Negative Pressure Wound Therapy Powered Suction Pump.

The system is portable, battery-operated, and intended for single-use or reusable applications in clinical settings such as hospitals, surgical centers, and outpatient care. It is regulated under FDA 510(k) clearance (K080275) and falls under the General and Plastic Surgery specialty. The device operates at low power and is intended for use with appropriate wound dressings and connectors as part of a complete negative pressure therapy setup. No MRI safety information or sterility specifications are provided in the data.

Frequently asked questions

What is the NPD 1000 Negative Pressure Wound Therapy System used for?

The NPD 1000 is designed for negative pressure wound therapy (NPWT), applying controlled suction to wound beds to remove exudate and infectious material. This process enhances granulation tissue formation and reduces bacterial load, accelerating wound healing in clinical environments like hospitals and outpatient care.

Is the NPD 1000 system single-use or reusable?

The NPD 1000 Negative Pressure Wound Therapy System is intended for both single-use and reusable applications, depending on clinical protocols and facility preferences. Reusability is typically determined by manufacturer guidelines and proper maintenance procedures to ensure device integrity and sterility.

What types of settings can use the NPD 1000?

This device is approved for use in clinical settings, including hospitals, surgical centers, and outpatient care facilities. Its portable, battery-operated design makes it suitable for mobile or bedside wound management where traditional stationary systems may be impractical.

Does the NPD 1000 come with specific wound dressings or connectors?

No, the NPD 1000 is intended to be used as part of a complete negative pressure therapy setup. It requires compatible wound dressings and connectors (not included) to function effectively. Always verify compatibility with the manufacturer’s instructions for optimal performance.

How is the NPD 1000 powered, and what are its operational limitations?

The NPD 1000 operates on low power and is battery-powered for portability. While it is designed for clinical use, its operational limitations—such as suction strength, battery life, and connectivity—are detailed in the manufacturer’s instructions. Ensure proper charging and maintenance to avoid interruptions during therapy.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Npd 1000 Negative Pressure Wound Therapy System, NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM… - FDA.report, Npd 1000 Negative Pressure Wound Therapy System - Beudamed

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Iasis Medical, Inc.

Sources (1)

  • FDA 510(k) K080275 24 fields · synced Oct 5, 2026