# K032301: Neogen One, Closed Wound Drain System, Part Number: NG9900

- Pathway: 510(k) (Traditional)
- Applicant: Neogen Technologies, Inc.
- Decided: Aug 21, 2003 after 27 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
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K050129: Celleration Mist Therapy System 5.1 (2005), 6 descendants of its own
- K062544: AR1000 Ultrasonic Wound Therapy System (2007), 5 descendants of its own
- K112782: Misonix Sonicone (R) Ultrasonic Wound Care System and Accessories (2011), 2 descendants of its own
- K072904: Sonoca 180/195 Wound Care System (2008), 1 descendant of its own
- K131096: AR1000 Series Ultrasonic Wound Therapy System (2014), 0 descendants of its own

## Indications for use
The NeoGen One device is indicated for patients who would benefit from a suction device, particularly as the use of that device may promote wound healing. This includes patients who would benefit from vacuum-assisted drainage and removal of infectious material or other fluids from wounds under influence of continuous and/or alternating vacuum pressure. This device is restricted to sale by, or on the order of, a physician or licensed practitioner.

Source page: https://510kreport.com/device/K032301
Methodology: https://510kreport.com/methodology