# K111949: AC Wound Treatment System

- Pathway: 510(k) (Traditional)
- Applicant: Nanovibronix, Inc.
- Decided: Jun 29, 2012 after 357 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: 6 generations back to K945062 (1995). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083375: Renasys GO Negative Pressure Wound Therapy, Smith & Nephew, Inc. (2009) Summary page 2.

## Indications for use
AC Wound Management System is indicated for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing fluids, including irrigation and body fluids, wound exudates, and infectious materials. Examples of appropriate wound types include: Diabetic/Neuropathic ulcers, Pressure ulcers, Chronic wounds, Acute wounds, Dehisced wounds, Partial-thickness burns, and Flaps and Grafts.

Source page: https://510kreport.com/device/K111949
Methodology: https://510kreport.com/methodology