# K090258: Venturi NPWT V. II Advanced Vacuum System

- Pathway: 510(k) (Traditional)
- Applicant: Talley Medical
- Decided: Aug 25, 2009 after 204 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: 4 generations back to K945062 (1995). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061919: Versatile 1 Ezcare Wound Vacuum System, Blue Sky Medical Group Incorporated (2007) Summary page 1.
- K082415: Prodigy NPWT System Model Prodigy 800V, Premco Medical Systems, Inc. (2008) Summary page 1.

## Most influential descendants
- K143004: VENTURI MiNO TG600/14 (2016), 0 descendants of its own

## Indications for use
Use of the VenturiTM NPWT v.11 Advanced Vacuum System is indicated for use in patients that 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 material from a patients airway or respiratory support system either during surgery or at the patient's bedside.

Source page: https://510kreport.com/device/K090258
Methodology: https://510kreport.com/methodology