# K103156: V.a.C. Veraflo Cleanse Dressing System

- Pathway: 510(k) (Special)
- Applicant: Kci USA, Inc. (Kinetic Concepts, Inc.)
- Decided: Mar 14, 2011 after 139 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). 6 ancestors in all.
3 later devices descend from it; 1 cites 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 1.

## Most influential descendants
- K160451: V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ... (2016), 2 descendants of its own
- K211521: 3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG) (2021), 1 descendant of its own
- K221585: 3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit (2023), 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 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. 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.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.

Source page: https://510kreport.com/device/K103156
Methodology: https://510kreport.com/methodology