# K210107: Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Genadyne Biotechnologies, Inc.
- Decided: Jun 1, 2022 after 502 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K253429: Genadyne ASTRA NPWT (2026), 0 descendants of its own
- K221888: Genadyne Hybrid Foam Dressings (2023), 0 descendants of its own

Source page: https://510kreport.com/device/K210107
Methodology: https://510kreport.com/methodology