# K052456: Modification to Versatile 1 Wound Vacuum System

- Pathway: 510(k) (Special)
- Applicant: Blue Sky Medical Group Incorporated
- Decided: Nov 4, 2005 after 58 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.
127 later devices descend from it; 6 cite it directly.
0 of 131 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042134: Versatile 1 Wound Vacuum System, Blue Sky Medical Group Incorporated (2004) Summary page 1.

## Most influential descendants
- 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
- K082426: Renasys EZ (2008), 58 descendants of its own
- K083375: Renasys GO Negative Pressure Wound Therapy (2009), 56 descendants of its own

## 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/K052456
Methodology: https://510kreport.com/methodology