# K113236: Foryou NPWT Device

- Pathway: 510(k) (Traditional)
- Applicant: Foryou Medical Electronics Co, Ltd.
- Decided: Feb 12, 2013 after 468 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). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082426: Renasys EZ, Smith & Nephew, Inc. (2008) Summary page 2.
- K063692: V.a.C. Therapy Systems-Acti V.a.C. Therapy Unit Model# 340000, Kci USA, Inc. (2007) Summary page 2.

## Indications for use
Foryou NPWT NP32 Device is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing through the removal of excess exudates, infectious material, and tissue debris.

Source page: https://510kreport.com/device/K113236
Methodology: https://510kreport.com/methodology