# K082676: Genadyne A4 Wound Vacuum System

- Pathway: 510(k) (Traditional)
- Applicant: Genadyne Biotechnologies, Inc.
- Decided: Dec 18, 2008 after 94 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: 4 generations back to K945062 (1995). 5 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061367: Bluesky Vista Wound Vacuum System, Model 100.0500, Blue Sky Medical Group Incorporated (2006) Summary page 1.

## Most influential descendants
- K140022: Nisus Negative Pressure Wound Therapy Pump, Nisus NPWT Canister 250-ML, Nisus NPWT Canister 500-ML, Cork Medical Product (2014), 5 descendants of its own
- K090638: Genadyne A4-XLR8 Wound Vacuum System (2009), 2 descendants of its own
- K243187: Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) (2025), 1 descendant of its own
- K230677: Cork Medical VERSA Negative Pressure Wound System (VCMPP-100) (2023), 1 descendant of its own
- K132004: NPWT Wound Dressing Kit- Medium, NPWT Wound Dressing Kit- Large (2014), 1 descendant of its own

## Indications for use
The Genadyne A4 Wound Vacuum System 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 excess exudates, infectious material and tissue debris.

Source page: https://510kreport.com/device/K082676
Methodology: https://510kreport.com/methodology