Invia Ease Negative Pressure Wound Therapy (NPWT) System
FDA 510(k)Class II (US FDA 510(k))
by Medela LLC
Identifiers
- 510(k) Number
- K214112 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 Invia Ease Negative Pressure Wound Therapy (NPWT) System is a powered suction pump designed for negative pressure wound therapy. It is classified as a Class II medical device under FDA regulation 878.4780 and has been determined to be substantially equivalent to a legally marketed predicate device.
The system is supplied as a single-patient-use device with a reusable pump component. It is intended for use in clinical settings and has received FDA 510(k) clearance under K214112. The device is manufactured by Medela LLC and is authorized for distribution in the United States.
Frequently asked questions
What is the Invia Ease NPWT System used for?
The Invia Ease NPWT System is a powered suction pump designed for negative pressure wound therapy, intended for use in clinical settings to apply controlled subatmospheric pressure to wounds.
How is the Invia Ease NPWT System supplied and is it reusable?
The system is supplied as a single-patient-use device with a reusable pump component, meaning the pump can be cleaned and reused for multiple patients while disposable components are discarded after each use.
What regulatory clearance does the Invia Ease NPWT System have?
The Invia Ease NPWT System has received FDA 510(k) clearance under K214112 and is classified as a Class II medical device under FDA regulation 878.4780, determined to be 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: PDF SINGLE-PATIENT-USE CONVENIENCE WITH REUSABLE PUMP PERFORMANCE - Medela, Medela Invia Ease Clinician Instructions For Use - ManualsLib, Medela | Wound Care | Negative Pressure Wound Therapy, Medela Invia Ease Manuals | ManualsLib
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K214112 | Class II | Active |
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Manufacturer
- Manufacturer
- Medela LLC
- FDA Applicant
- Medela AG
Sources (1)
- FDA 510(k) K214112 24 fields · synced Oct 1, 2026