# K162790: V.A.C.ULTA Negative Pressure Wound Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Kci USA, Inc. (Kinetic Concepts, Inc.)
- Decided: Jan 26, 2017 after 114 days
- Product code: OMP (Negative Pressure Wound Therapy Powered Suction Pump)
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K945062 (1995). 6 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100657: V.a.C. Ulta Negative Pressure Wound Therapy System (V.a.C. Ulta Therapy System) Model V.a.C. Ulta Therapy Unit Model U, Kci USA, Inc. (Kinetic Concepts, Inc.) (2010) Summary page 4.

## Most influential descendants
- K203316: V.A.C.ULTA Negative Pressure Wound Therapy System (2021), 1 descendant of its own
- K261338: RENASYS DYNAFLOW Kit (66807741) (2026), 0 descendants of its own
- K233614: Genadyne DUO NPWT (2024), 0 descendants of its own

## Recalls of this device
- Nov 5, 2024 · Class II · Z-0507-2025: Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.

## Indications for use
The V.A.C.ULTA™ Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option. • Negative Pressure Wound Therapy in the absence of instillation is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. • Instillation Therapy 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 V.A.C.ULTA™ Negative Pressure Wound Therapy System with and without instillation is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts. • Negative Pressure Wound Therapy in the absence of instillation may also be used for: o The temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary and for open abdominal wounds with exposed viscera including, but not limited to, abdominal compartment syndrome. The intended care setting is a closely monitored area within the acute care hospital, such as the ICU. The abdominal dressing will most often be applied in the operating theater. o The management of the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy.

Source page: https://510kreport.com/device/K162790
Methodology: https://510kreport.com/methodology