# K151263: Venturi Gauze Wound Care Sets with Portal Drain

- Pathway: 510(k) (Traditional)
- Applicant: Talley Group, Ltd.
- Decided: Feb 19, 2016 after 282 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: 7 generations back to K945062 (1995). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080897: Venturi Negative Pressure Wound Therapy System, Talley Medical (2008) Summary page 4.
- K122132: Avance Foam Dressing Kit Incl. Transparent Film, Transfer Pad (Small, Medium, Large) Avance Transparent Film Avance Foam, Molnlycke Health Care (2013) Summary page 4.

## Most influential descendants
- K161948: Avance Gauze Dressing Kits (2016), 0 descendants of its own

## Indications for use
Venturi™ Gauze Wound Care Sets with Portal Drain are intended to be used with the Talley Group range of negative pressure wound therapy pumps. The Talley Group NPWT pumps are indicated use for patients with acute or chronic wounds that may be benefitted by the application of continual negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The device is intended for use by qualified healthcare professionals in a healthcare environment. NPWT is contraindicated for patients with: 1. Malignancy in the wound 2. Untreated osteomyelitis 3. Non-enteric and unexplored fistulas 4. Wounds with difficult haemostasis 5. Necrotic tissue with eschar present 6. Exposed vasculature, bone, nerves, or organs

Source page: https://510kreport.com/device/K151263
Methodology: https://510kreport.com/methodology