# K161432: MyNeWT Negative Pressure Wound Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Stortford Medical, LLC
- Decided: Feb 8, 2017 after 260 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: 8 generations back to K945062 (1995). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112127: Pico Single Use Negative Pressure Wound Therapy System, Smith & Nephew, Inc. (2012) Summary page 4.
- K132741: V.a.C. Via Negative Pressure Wound Therapy System, Kci USA, Inc. (2013) Summary page 5.

## Indications for use
The myNeWT System is indicted for patients who would benefit from Negative Pressure Wound Therapy as it may promote wound healing by removing low to moderate levels (< 37.5 ml/day) of exudate and infectious materials. Appropriate wound types include: • Chronic wounds • Acute, Sub-acute and dehisced wounds • Traumatic wounds • Partial thickness burns • Pressure or venous insufficiency ulcers • Diabetic ulcers • Flaps and grafts • Closed incision sites

Source page: https://510kreport.com/device/K161432
Methodology: https://510kreport.com/methodology