# K080897: Venturi Negative Pressure Wound Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Talley Medical
- Decided: Jul 15, 2008 after 106 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.
4 later devices descend from it; 3 cite it directly.
0 of 11 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)
- K061788: Boehringer Laboratories Suction Pump System, Boehringer Laboratories (2006) Summary page 1.

## Most influential descendants
- K151263: Venturi Gauze Wound Care Sets with Portal Drain (2016), 1 descendant of its own
- K161948: Avance Gauze Dressing Kits (2016), 0 descendants of its own
- K161797: Avance Tubing, Avance Y-Connector, Avance ViewPad (2016), 0 descendants of its own
- K143004: VENTURI MiNO TG600/14 (2016), 0 descendants of its own

## Indications for use
Use of the VenturjTM Negative Pressure Wound Therapy system is indicated for use for patients with acute or chronic wounds that may be benefited by the application of negative pressure therapy and the potential wound healing effects of removal of fluids induding wound exudates, irrigation flUids, body fluids, and infectious materials. Venturi is intended for use in acute care settings only.

Source page: https://510kreport.com/device/K080897
Methodology: https://510kreport.com/methodology