# K203316: V.A.C.ULTA Negative Pressure Wound Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Kci, A Part of 3M Health Care Business Group
- Decided: Oct 27, 2021 after 351 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). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162790: V.A.C.ULTA Negative Pressure Wound Therapy System, Kci USA, Inc. (Kinetic Concepts, Inc.) (2017) Summary page 4.

## Most influential descendants
- K261338: RENASYS DYNAFLOW Kit (66807741) (2026), 0 descendants of its own

## 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 (V.A.C.® Therapy) with an instillation option (Veraflo™ Therapy). • V.A.C.® 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. • Veraflo™ 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. V.A.C.® 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/K203316
Methodology: https://510kreport.com/methodology