# K180415: Invia White Foam NPWT

- Pathway: 510(k) (Traditional)
- Applicant: Medela AG
- Decided: Nov 2, 2018 after 260 days
- Product code: OMP (Negative Pressure Wound Therapy Powered Suction Pump)
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K945062 (1995). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170088: Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film, Medela AG (2017) Summary page 4.
- K142646: XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and, Genadyne Biotechnologies, Inc. (2015) Summary page 4.

## Indications for use
The Invia White Foam in conjunction with the Invia Foam Dressing Kits with FitPad, the Invia Motion and Invia Liberty Negative Pressure Wound Therapy (NPWT) systems is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. The Invia White Foam is appropriate for use for the following wounds: – Acute or sub-acute wounds – Chronic wounds – Dehisced wounds – Pressure ulcers – Diabetic/neuropathic ulcers – Venous insufficiency ulcers – Traumatic wounds – Partial thickness burns – Flaps and grafts

Source page: https://510kreport.com/device/K180415
Methodology: https://510kreport.com/methodology