# K221888: Genadyne Hybrid Foam Dressings

- Pathway: 510(k) (Traditional)
- Applicant: Genadyne Biotechnologies, Inc.
- Decided: Jun 12, 2023 after 348 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: 1 generation back to K210107 (2022). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210107: Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System, Genadyne Biotechnologies, Inc. (2022) Summary page 4.

## Indications for use
Genadyne Hybrid Foam Dressings when used in conjunction with the XLR8+, UNO30 and UNO Plus NPWT System is indicated to help promote wound healing, through means including drainage and removal of infectious material or other fluids, under the influence of continuous and/or intermittent negative pressures, particularly for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

Source page: https://510kreport.com/device/K221888
Methodology: https://510kreport.com/methodology