# K150960: WoundPro Negative Pressure Wound Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Pensar Medical, LLC
- Decided: Dec 1, 2016 after 601 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: 5 generations back to K945062 (1995). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100823: Wound Pro Apex, Accuro Medical Products, LLC (2011) Summary page 4.
- K080357: Medela Invia Wound Therapy, Medela AG (2008) Summary page 4.

## Indications for use
The WoundPro Negative Pressure Wound Therapy System may promote wound healing, through the drainage and removal of infectious material and other fluids from the wound site, with continuous and/or, intermittent negative pressure. Patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts may benefit from the use of this device. The WoundPro is intended for use in a healthcare facility only. Additional Wounds Indicated are: · Diabetic/Neuropathic ulcers · Pressure ulcers · Chronic wounds · Acute wounds · Dehisced wounds

Source page: https://510kreport.com/device/K150960
Methodology: https://510kreport.com/methodology