# K151326: RENASYS¿ EZ PLUS Negative Pressure Wound Therapy Device

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 16, 2015 after 59 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: 10 generations back to K945062 (1995). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142979: RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft Port; Gauze NPWT Wound Dressing Kits with Soft Port; EZ PLUS/EZ MAX Canisters, Smith & Nephew, Inc. (2015) Summary page 4.

## Indications for use
The RENASYS EZ PLUS NPWT is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of fluids, including irrigation and body fluids, wound exudates and infectious materials Appropriate wound types include: • Chronic • Acute • Traumatic • Sub-acute and dehisced wounds • Ulcers (such as pressure or diabetic) • Partial-thickness burns • Flaps and grafts RENASYS EZ PLUS professional healthcare facility model (REF 66800697) is intended for use in acute care settings and other professional healthcare environments where product use is conducted by or under the supervision of a qualified healthcare professional.

Source page: https://510kreport.com/device/K151326
Methodology: https://510kreport.com/methodology