# K182191: Invia Abdominal Dressing Kit

- Pathway: 510(k) (Traditional)
- Applicant: Medela AG
- Decided: Feb 1, 2019 after 172 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: 8 generations back to K945062 (1995). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130852: Avance® Foam Abdominal Dressing Kit, Molnlycke Health Care (2014) Summary page 4.

## Indications for use
The Invia Abdominal Dressing Kit is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries may be required. Its intended use is with patients who have open abdominal wounds with exposed viscera and organs, and including but not limited to patients with abdominal compartment syndrome. It is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre. The dressing kit is intended for use together with the Invia Liberty NPWT System.

Source page: https://510kreport.com/device/K182191
Methodology: https://510kreport.com/methodology