# K022011: V.a.C. Abdominal Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Kinetic Concepts, Inc.
- Decided: Feb 26, 2003 after 252 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- 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: 2 generations back to K945062 (1995). 4 ancestors in all.
17 later devices descend from it; 4 cite it directly.
0 of 22 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 2.
- K983753: Star Temporary Wound Cover, Osteogenics, Inc. (1999) Summary page 1.

## Most influential descendants
- K100787: Renasys F/-AB Abdominal Wound Dressing Kit (2010), 11 descendants of its own
- K112784: Renasys AB Abominal Dressing Kit (2011), 10 descendants of its own
- K143133: RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing Kit with Soft Port Device (2015), 5 descendants of its own
- K181822: RENASYS Touch; RENASYS Y-Connector (2019), 3 descendants of its own
- K130852: Avance® Foam Abdominal Dressing Kit (2014), 3 descendants of its own

## Recalls of this device
- Mar 17, 2006 · Not classified · Z-0873-06: Complaints received regarding difficulty opening the nonadherent layer of the device prior to application to open abdominal wounds.

## Indications for use
The V.A.C. Abdominal Dressing is a specialty dressing indicated for temporary bridging of abdominal wall openings where primary closure is not possible and or repeat abdominal entries are necessary. The Intended Use of this dressing is for use in open abdominal wounds, with exposed viscera, including but not limited to abdominal compartment syndrome. The intended care setting is the acute hospital setting: in trauma, general and plastic surgery wards. The abdominal dressing will most often be applied in the operating theater.

Source page: https://510kreport.com/device/K022011
Methodology: https://510kreport.com/methodology