# K253429: Genadyne ASTRA NPWT

- Pathway: 510(k) (Traditional)
- Applicant: Genadyne Biotechnologies, Inc.
- Decided: Mar 12, 2026 after 162 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 5.

## Indications for use
Genadyne Astra NPWT System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device can be used for wound management by the removal of excess exudates, infectious material and tissue debris. Appropriate wound type include: - Chronic - Acute - Traumatic - Subacute and dehisced wounds - Partial thickness burns - Ulcers (such as diabetic or pressure) - Flaps and grafts For use by healthcare professional and home use. This NPWT System can only be used with approved dressing kits under K233614.

Source page: https://510kreport.com/device/K253429
Methodology: https://510kreport.com/methodology