Medela Invia Wound Therapy
FDA 510(k)Class II (US FDA 510(k))
by Medela LLC
Identifiers
- 510(k) Number
- K080357 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 Medela Invia Wound Therapy is a negative pressure wound therapy powered suction pump. It delivers therapy by controlling set pressure at the wound site and dynamically adapting airflow cycles to optimize exudate removal. The device is compatible with both foam and gauze dressings and offers clinical flexibility with pressure settings and therapy modes.
The Invia Wound Therapy is supplied as a single-patient-use device with a reusable pump. It features a click-in canister attachment and one-touch canister release button for easy canister exchange, with secure tubing attachment. The device is FDA 510(k) cleared with product code OMP and is regulated under 878.4780.
Frequently asked questions
What is the Medela Invia Wound Therapy used for?
The Medela Invia Wound Therapy is a negative pressure wound therapy powered suction pump designed to deliver therapy by controlling set pressure at the wound site and dynamically adapting airflow cycles to optimize exudate removal. It is compatible with both foam and gauze dressings, offering clinical flexibility in pressure settings and therapy modes for wound management.
How is the Medela Invia Wound Therapy supplied and is it reusable?
The Medela Invia Wound Therapy is supplied as a single-patient-use device with a reusable pump. This means the pump unit can be reused across multiple patients after appropriate cleaning, while disposable components such as the canister and tubing are intended for single-patient use to maintain hygiene and safety.
What are the key features of the Medela Invia Wound Therapy pump?
The Medela Invia Wound Therapy features a click-in canister attachment and a one-touch canister release button for easy and secure canister exchange. It also includes secure tubing attachment and is designed to dynamically adapt airflow cycles to optimize exudate removal while maintaining set pressure at the wound site.
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: PDF SINGLE-PATIENT-USE CONVENIENCE WITH REUSABLE PUMP PERFORMANCE - Medela, PDF Invia Liberty NPWT System - Medela, Medela | Wound Care | Negative Pressure Wound Therapy
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K080357 | Class II | Active |
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Manufacturer
- Manufacturer
- Medela LLC
- FDA Applicant
- Medela AG
Sources (1)
- FDA 510(k) K080357 24 fields · synced Sep 28, 2026