# K182722: XLR8 Abdominal Wound Dressing Kit

- Pathway: 510(k) (Traditional)
- Applicant: Genadyne Biotechnologies
- Decided: Sep 27, 2019 after 364 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). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161939: Avance Abdominal Dressing Kit, Molnlycke Health Care Us, LLC (2016) Summary page 4.

## Indications for use
XLR8 Abdominal Wound Dressing Kit is indicated for use in conjunction with Genadyne NPWT System's XLR8+ for patients who have open abdominal wounds with exposed viscera and organs, including but not limited to patients with abdominal compartment syndrome. XLR8 Abdominal Wound dressing foam is used for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries may be required. It is intended for use in acute hospital setting(trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.

Source page: https://510kreport.com/device/K182722
Methodology: https://510kreport.com/methodology