# K093564: Sved Wound Treatment System

- Pathway: 510(k) (Special)
- Applicant: Innovative Therapies, Inc.
- Decided: Nov 25, 2009 after 7 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.
2 later devices descend 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)
- K071301: Antlia I Wound Irrigation System, Innovative Therapies, Inc. (2007) Summary page 1.

## Most influential descendants
- K142916: SVED Wound Treatment System (2015), 1 descendant of its own
- K231646: Carilex VT¿200-i NX (2024), 0 descendants of its own

## Indications for use
The Sved®Wound Treatment System is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed. The intended use for the Sved® Wound Treatment System is for patients with chronic, acute, traumatic, subacute and dehisced wounds, diabetic ulcers, pressure ulcers, flaps and grafts.

Source page: https://510kreport.com/device/K093564
Methodology: https://510kreport.com/methodology