# K141437: XLR8 Plus (XLR8+)

- Pathway: 510(k) (Special)
- Applicant: Genadyne Biotechnologies, Inc.
- Decided: Sep 19, 2014 after 112 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: 6 generations back to K945062 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090638: Genadyne A4-XLR8 Wound Vacuum System, Genadyne Biotechnologies, Inc. (2009) Summary page 4.

## Indications for use
The XLR8 Plus (XLR8+) Wound Vacuum System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates, infectious material and tissue debris.

Source page: https://510kreport.com/device/K141437
Methodology: https://510kreport.com/methodology