# DEN180013: PREVENA 125 and PREVENA PLUS 125 Therapy Units

- Pathway: De Novo (Direct)
- Applicant: Kci USA, Inc.
- Decided: Apr 19, 2019 after 400 days
- Product code: QFC (Negative Pressure Wound Therapy Device For Reduction Of Wound Complications)
- Device class: 2
- Regulation: 21 CFR 878.4783
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K223263: Prevena Plus 125 Therapy Unit (2023), 0 descendants of its own
- K203716: PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System (2021), 0 descendants of its own

## Indications for use
PREVENA 125 and PREVENA PLUS 125 Therapy Units manage the environment of closed surgical incisions and remove fluid away from the surgical incision via the application of -125mmHg continuous negative pressure. When used with legally marketed compatible dressings, PREVENA 125 and PREVENA PLUS 125 Therapy Units are intended to aid in reducing the incidence of seroma and, in patients at high risk for post-operative infections, aid in reducing the incidence of superficial surgical site infection in Class I and Class II wounds.

Source page: https://510kreport.com/device/DEN180013
Methodology: https://510kreport.com/methodology