# K042134: Versatile 1 Wound Vacuum System

- Pathway: 510(k) (Traditional)
- Applicant: Blue Sky Medical Group Incorporated
- Decided: Nov 1, 2004 after 84 days
- Product code: OMP (Negative Pressure Wound Therapy Powered Suction Pump)
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K945062 (1995). 2 ancestors in all.
159 later devices descend from it; 10 cite it directly.
1 of 162 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945062: Vacplus, Kinetic Concepts, Inc. (1995) Summary page 4.
- K983552: Basic, Median, Dominant, and Vario, Medela, Inc. (1999) Summary page 4.

## Most influential descendants
- K052456: Modification to Versatile 1 Wound Vacuum System (2005), 127 descendants of its own
- K061435: Medela Vario Suction Pumps (2006), 120 descendants of its own
- K070904: Antlia II Suction Pump System (2007), 109 descendants of its own
- K061919: Versatile 1 Ezcare Wound Vacuum System (2007), 107 descendants of its own
- K082211: Renasys-F Negative Pressure Wound Therapy Foam Dressing Kits (2008), 68 descendants of its own

## Recalls of this device
- Aug 7, 2008 · Not classified · Z-0162-2009: External battery chargers used with the Version 29 VISTA Negative Pressure Wound Therapy pumps are failing to properly charge the pump's battery.
- Mar 31, 2008 · Not classified · Z-1620-2008: Incorrect labeling. Kit labels may incorrectly state that a flat drain is contained as a kit component while some kits may contain a round drain.

## Indications for use
The Versatile 1 Wound Vacuum System is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing or for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids, or infectious materials from a patients airway or respiratory support system either during surgery or at the patients bedside.

Source page: https://510kreport.com/device/K042134
Methodology: https://510kreport.com/methodology