Activ.A.C. Negative Pressure Wound Therapy System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K201571 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 Activ.A.C. Negative Pressure Wound Therapy System is a powered suction pump designed for negative pressure wound therapy (NPWT). It promotes wound healing by applying controlled negative pressure to the wound bed, reducing edema, enhancing granulation tissue formation, and improving perfusion. This system is classified as a Class II medical device under FDA regulations and is intended for use in general and plastic surgery settings.
The device is supplied as a portable, ambulatory unit suitable for use in clinical and home care environments. It is intended for single-use applications, though specific components may be reusable depending on manufacturer guidelines. The system operates within defined safety parameters for MRI compatibility and includes various pressure settings and alert functions. Authorized under FDA 510(k) clearance (K201571), it adheres to regulatory standards outlined in 21 CFR 878.4780 and is intended for use with compatible wound dressings and accessories.
Frequently asked questions
What is the Activ.A.C. Negative Pressure Wound Therapy System used for?
The Activ.A.C. Negative Pressure Wound Therapy System is designed to promote wound healing by applying controlled negative pressure to the wound bed. This helps reduce edema (swelling), enhances the formation of granulation tissue, and improves blood flow to the wound area. It is intended for use in general and plastic surgery settings to support healing in chronic or acute wounds.
Is the Activ.A.C. NPWT System portable and suitable for home use?
Yes, the Activ.A.C. Negative Pressure Wound Therapy System is supplied as a portable, ambulatory unit. This makes it suitable for use in both clinical environments, such as hospitals, and home care settings, allowing patients to continue treatment outside of a healthcare facility.
How is the Activ.A.C. NPWT System intended for use—single-use or reusable?
The Activ.A.C. Negative Pressure Wound Therapy System itself is intended for single-use applications. However, some components of the system may be reusable, depending on the manufacturer’s guidelines. It is important to follow the specific instructions provided by KCI USA, Inc. to ensure proper use and sterility.
Does the Activ.A.C. NPWT System have MRI compatibility?
Yes, the Activ.A.C. Negative Pressure Wound Therapy System includes safety parameters for MRI compatibility. This means it is designed to be used safely in environments where MRI scans are performed, provided the system is operated according to the manufacturer’s instructions and guidelines.
What regulatory approval does the Activ.A.C. NPWT System hold?
The Activ.A.C. Negative Pressure Wound Therapy System is authorized under FDA 510(k) clearance with the clearance number K201571. It is classified as a Class II medical device and adheres to regulatory standards outlined in 21 CFR 878.4780. This clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device.
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: 3M™ ActiV.A.C.™ Therapy Unit, PDF 3M ActiV.A.C. Therapy System Brochure, KCI ACTIV.A.C Negative Pressure Wound Therapy Unit User Guide, Negative pressure wound therapy unit - ActiV.A.C. - Kinetic Concepts
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201571 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Kci Usa, Inc.
Sources (1)
- FDA 510(k) K201571 24 fields · synced Oct 1, 2026