# K142916: SVED Wound Treatment System

- Pathway: 510(k) (Traditional)
- Applicant: Cardinalhealth
- Decided: Mar 4, 2015 after 148 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: 5 generations back to K945062 (1995). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093564: Sved Wound Treatment System, Innovative Therapies, Inc. (2009) Summary page 4.

## Most influential descendants
- K231646: Carilex VT¿200-i NX (2024), 0 descendants of its own

## Indications for use
The Cardinal Health NPWT SVED system is an integrated wound management system, indicated for the application of continual or intermittent negative pressure wound therapy to the wound as the device may promote wound healing by the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious materials. The system is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The system is intended for use in acute, extended and home care settings.

Source page: https://510kreport.com/device/K142916
Methodology: https://510kreport.com/methodology