# K161599: UNO Negative Pressure Wound Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Genadyne Biotechnologies, Inc.
- Decided: Apr 6, 2017 after 301 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). 24 ancestors in all.
4 later devices descend 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)
- K151436: PICO Single Use Negative Pressure Wound Therapy System, Smith & Nephew Medical, Ltd. (2016) Summary page 4.

## Most influential descendants
- K180840: UNO Negative Pressure Wound Therapy System (2018), 3 descendants of its own
- K190028: UNO 30 (2020), 1 descendant of its own
- K221891: UNO Negative Pressure Wound Therapy System (2022), 0 descendants of its own
- K181929: MiMo (TM) Negative Pressure Wound Therapy System (2019), 0 descendants of its own

## Indications for use
Genadyne UNO 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 - Partial-thickness burns - Ulcers (such as diabetic or pressure) - Flaps and grafts Genadyne UNO is a single patient use device.

Source page: https://510kreport.com/device/K161599
Methodology: https://510kreport.com/methodology