# K223263: Prevena Plus 125 Therapy Unit

- Pathway: 510(k) (Traditional)
- Applicant: 3M
- Decided: Feb 13, 2023 after 112 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K945062 (1995). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN180013: PREVENA 125 and PREVENA PLUS 125 Therapy Units, Kci USA, Inc. (2019) Summary page 4.
- K180855: Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System, Kci USA, Inc. (2018) Summary page 4.

## Recalls of this device
- Jan 17, 2025 · Class II · Z-1175-2025: Due to increase in complaints related to leak alarms

## Indications for use
Prevena Plus 125 Therapy Unit is indicated for use with both the Prevena™ Dressings and compatible V.A.C.® Dressings. The Prevena Plus 125 Therapy Unit when used with the Prevena™ Dressings (Prevena Plus Incision Management System), manages the environment of closed surgical incisions and removes fluid away from the surgical incision via the application of -125mmHg continuous negative pressure. When used with legally marketed Prevena Dressings for up to seven days, 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. The Prevena ™ Plus 125 Therapy Unit, when used with compatible V.A.C.® Dressings on open wounds (Prevena Plus Negative Pressure Wound Therapy System), is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.

Source page: https://510kreport.com/device/K223263
Methodology: https://510kreport.com/methodology