# K132446: Renasys EZ Max Negative Pressure Wound Therapy Device

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Oct 23, 2013 after 78 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). 19 ancestors in all.
13 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)
- K102001: Modification to Renasys EZ Plus Negative Pressure Wound Therapy, Smith & Nephew, Inc. (2010) Summary page 1.

## Most influential descendants
- 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 (2015), 12 descendants of its own
- K153209: RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters,  RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply (2016), 5 descendants of its own
- K143133: RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing Kit with Soft Port Device (2015), 5 descendants of its own
- K181822: RENASYS Touch; RENASYS Y-Connector (2019), 3 descendants of its own
- K223041: Renasys Edge (66803126) (2022), 2 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. Examples of appropriate wound types include: * Chronic * Acute * Traumatic * Sub-acute and dlehisced wounds * Ulcers (such as pressure or diabetic) * Partial-thickness burns * Flaps and grafts The RENASYS EZ MAX Professional Healthcare Facility model (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.

Source page: https://510kreport.com/device/K132446
Methodology: https://510kreport.com/methodology