# K132004: NPWT Wound Dressing Kit- Medium, NPWT Wound Dressing Kit- Large

- Pathway: 510(k) (Traditional)
- Applicant: Creo Quality, LLC
- Decided: May 2, 2014 after 305 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: 6 generations back to K945062 (1995). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082676: Genadyne A4 Wound Vacuum System, Genadyne Biotechnologies, Inc. (2008) Summary page 1.
- K092992: A4-XLR8 Foam Dressing, Genadyne Biotechnologies, Inc. (2010) Summary page 1.

## Most influential descendants
- K182458: Longterm NPWT Foam Dressing Kit (2019), 0 descendants of its own

## Indications for use
Cork Medical Products NPWT Wound Dressing Kit is intended to be used in conjunction with the Genadyne XLR8 Pump to deliver negative pressure wound therapy to the wound. When used in conjunction with a NPWT pump system, Cork Medical Products NPWT Wound Dressing Kit is indicated for patients who would benefit from a suction device 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/K132004
Methodology: https://510kreport.com/methodology