# K190028: UNO 30

- Pathway: 510(k) (Traditional)
- Applicant: Genadyne Biotechnologies
- Decided: Jan 15, 2020 after 373 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: 11 generations back to K945062 (1995). 27 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180840: UNO Negative Pressure Wound Therapy System, Genadyne Biotechnologies, Inc. (2018) Summary page 4.
- K180205: AVELLE Negative Pressure Wound Therapy System, Convatec Limited (2018) Summary page 4.

## Most influential descendants
- K221891: UNO Negative Pressure Wound Therapy System (2022), 0 descendants of its own

## Indications for use
UNO 30 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 UNO 30 is a single patient use device.

Source page: https://510kreport.com/device/K190028
Methodology: https://510kreport.com/methodology