# K143133: RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing Kit with Soft Port Device

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 23, 2015 after 265 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). 27 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132446: Renasys EZ Max Negative Pressure Wound Therapy Device, Smith & Nephew, Inc. (2013) Summary page 5.
- K102001: Modification to Renasys EZ Plus Negative Pressure Wound Therapy, Smith & Nephew, Inc. (2010) Summary page 5.
- K112784: Renasys AB Abominal Dressing Kit, Smith & Nephew, Inc. (2011) Summary page 5.
- 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). Cleared while this submission was under review Summary page 6.

## Most influential descendants
- K181822: RENASYS Touch; RENASYS Y-Connector (2019), 3 descendants of its own
- K223041: Renasys Edge (66803126) (2022), 2 descendants of its own
- K231939: Renasys Edge (2024), 1 descendant of its own
- K260646: Renasys Edge (66803126) (2026), 0 descendants of its own
- K181204: RENASYS Y-Connector; RENASYS TOUCH (2019), 0 descendants of its own

## Indications for use
RENASYS EZ MAX 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 MAX professional healthcare facility model (REF 66801309) 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. RENASYS AB Abdominal Kit with Soft Port is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary. It is intended to be used in open abdominal wounds with exposed viscera, including but not limited to abdominal compartment syndrome. It is intended for use in acute hospital care settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.

Source page: https://510kreport.com/device/K143133
Methodology: https://510kreport.com/methodology