# K061919: Versatile 1 Ezcare Wound Vacuum System

- Pathway: 510(k) (Traditional)
- Applicant: Blue Sky Medical Group Incorporated
- Decided: Feb 5, 2007 after 214 days
- Product code: OMP (Negative Pressure Wound Therapy Powered Suction Pump)
- Device class: 2
- Regulation: 21 CFR 878.4780
- 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: 3 generations back to K945062 (1995). 4 ancestors in all.
107 later devices descend from it; 3 cite it directly.
0 of 112 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.
- K052456: Modification to Versatile 1 Wound Vacuum System, Blue Sky Medical Group Incorporated (2005) Summary page 1.

## Most influential descendants
- 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
- K110647: Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT Wound Dressing Kits with Suction Pad; Renasys (2011), 48 descendants of its own
- K092992: A4-XLR8 Foam Dressing (2010), 31 descendants of its own

## Recalls of this device
- Jul 21, 2016 · Class II · Z-2848-2016: Sterility seal integrity failures on the Renasys Sterile Transparent Film

## Indications for use
The Versatile 1 EZCare TM Wound Vacuum System is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing.

Source page: https://510kreport.com/device/K061919
Methodology: https://510kreport.com/methodology