# K241061: VERSA Negative Pressure Wound Therapy System (VCMPP-100)

- Pathway: 510(k) (Traditional)
- Applicant: Cork Medical
- Decided: Aug 21, 2024 after 125 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: 8 generations back to K945062 (1995). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230677: Cork Medical VERSA Negative Pressure Wound System (VCMPP-100), Cork Medical (2023) Summary page 5.

## Indications for use
The VERSA Negative Pressure Wound Therapy 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. The VERSA Negative Pressure Wound Therapy System is only intended to be used with the Cork NPWT Wound Dressing Kit (K132004) and the VERSA NPWT 100ml Canister. The VERSA Negative Pressure Wound Therapy System is suitable for use in both a professional healthcare facility and home use environment.

Source page: https://510kreport.com/device/K241061
Methodology: https://510kreport.com/methodology
