# K061367: Bluesky Vista Wound Vacuum System, Model 100.0500

- Pathway: 510(k) (Traditional)
- Applicant: Blue Sky Medical Group Incorporated
- Decided: Aug 10, 2006 after 86 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: 3 generations back to K945062 (1995). 4 ancestors in all.
24 later devices descend from it; 3 cite it directly.
0 of 29 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
- K082676: Genadyne A4 Wound Vacuum System (2008), 11 descendants of its own
- K100823: Wound Pro Apex (2011), 10 descendants of its own
- K132225: Extricare (2014), 8 descendants of its own
- K140022: Nisus Negative Pressure Wound Therapy Pump, Nisus NPWT Canister 250-ML, Nisus NPWT Canister 500-ML, Cork Medical Product (2014), 5 descendants of its own
- K140634: extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam Dressing Kit (2014), 4 descendants of its own

## Indications for use
The BlueSky VISTA™ 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/K061367
Methodology: https://510kreport.com/methodology