# 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

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Apr 29, 2015 after 196 days
- Product code: OMP (Negative Pressure Wound Therapy Powered Suction Pump)
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K945062 (1995). 22 ancestors in all.
12 later devices descend from it; 6 cite it directly.
0 of 35 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.
- K110647: Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT Wound Dressing Kits with Suction Pad; Renasys, Smith & Nephew, Inc. (2011) Summary page 5.

## Most influential descendants
- 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
- K243576: RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port (2025), 1 descendant of its own

## Recalls of this device
- Jul 21, 2016 · Class II · Z-2848-2016: Sterility seal integrity failures on the Renasys Sterile Transparent Film

## Indications for use
The RENASYS EZ MAX 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 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. The RENASYS Foam and Gauze Wound Dressing Kits with Soft Port are intended to be used in conjunction with Smith & Nephew NPWT (Negative Pressure Wound Therapy) systems. Smith & Nephew RENASYS systems are indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via the 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.

Source page: https://510kreport.com/device/K142979
Methodology: https://510kreport.com/methodology