# K221891: UNO Negative Pressure Wound Therapy System

- Pathway: 510(k) (Special)
- Applicant: Genadyne Biotechnologies, Inc.
- Decided: Dec 14, 2022 after 168 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: 12 generations back to K945062 (1995). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190028: UNO 30, Genadyne Biotechnologies (2020) Summary page 4.

## Indications for use
Genadyne UNO Negative Pressure Wound Therapy 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 low to moderate exudates and infectious material. Appropriate wound types include: - Chronic - Acute - Traumatic - Subacute and dehisced wounds - Ulcers (such as diabetic or pressure) - Flaps and grafts - Closed Surgical Incision Genadyne UNO Negative Pressure Wound Therapy System is a single patient use device.

Source page: https://510kreport.com/device/K221891
Methodology: https://510kreport.com/methodology