# 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

- Pathway: 510(k) (Traditional)
- Applicant: Kci USA, Inc. (Kinetic Concepts, Inc.)
- Decided: Sep 17, 2010 after 193 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: 3 generations back to K945062 (1995). 5 ancestors in all.
19 later devices descend from it; 3 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021501: V.a.C. Instillamat (Vacuum Assisted Closure Instillamat, Kinetic Concepts, Inc. (2002)
- K091585: Vac Therapy System, Models 340000, M8259999, 320000, M8259968 and 320100, Kci USA, Inc. (2009) Summary page 1.

## Most influential descendants
- K141017: Prevena Incision Management System with Peel & Dressing, Prevena Incision Management System with Customizable Dressing, (2015), 10 descendants of its own
- K153199: Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-Pack, Prevena Plus Incision Management System Kit with Customizable Dressing, Prevena Plus Customizable Dressing 5-Pack (2016), 9 descendants of its own
- K161897: PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings (2016), 8 descendants of its own
- K173426: PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System (2018), 7 descendants of its own
- K180855: Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System (2018), 5 descendants of its own

## Indications for use
The V.A. C.U/ta Negat/ve 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 exudt and infetius materia The instillation option 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.U/ta Tm 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 dia6etic, pressure and venous insufficiency), flaps and grafts.

Source page: https://510kreport.com/device/K100657
Methodology: https://510kreport.com/methodology