# K021501: V.a.C. Instillamat (Vacuum Assisted Closure Instillamat

- Pathway: 510(k) (Traditional)
- Applicant: Kinetic Concepts, Inc.
- Decided: Dec 2, 2002 after 207 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: 2 generations back to K945062 (1995). 3 ancestors in all.
30 later devices descend from it; 4 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992448: V.a.C. Plus, Kinetic Concepts, Inc. (2000) Summary page 1.
- K971548: Ambuvac, Kinetic Concepts, Inc. (1997) Summary page 1.

## Most influential descendants
- 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 (2010), 19 descendants of its own
- 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

## Indications for use
The V.A.C. Instillamat device 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. is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, diabetic ulcers, pressure ulcers, flaps and grafts.

Source page: https://510kreport.com/device/K021501
Methodology: https://510kreport.com/methodology