# K253263: ConvaVAC™ Negative Pressure Wound Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Convatec Limited, Gdc Building
- Decided: Jun 24, 2026 after 268 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: 10 generations back to K945062 (1995). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180205: AVELLE Negative Pressure Wound Therapy System, Convatec Limited (2018) Summary page 5.

## Indications for use
The ConvaVAC™ Negative Pressure Wound Therapy (NPWT) System is intended for patients who would benefit from negative pressure wound therapy for wound management via the removal of fluids including exudate, infectious materials and wound debris. The ConvaVAC™ NPWT System is indicated for low to moderately exuding wounds such as: • Chronic wounds i.e., diabetic foot ulcers, leg ulcers such as venous, arterial, and pressure ulcers • Traumatic wounds • Dehisced wounds • Flaps and grafts • Closed surgical incisions

Source page: https://510kreport.com/device/K253263
Methodology: https://510kreport.com/methodology