# K102001: Modification to Renasys EZ Plus Negative Pressure Wound Therapy

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Aug 6, 2010 after 22 days
- Product code: OMP (Negative Pressure Wound Therapy Powered Suction Pump)
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K945062 (1995). 18 ancestors in all.
14 later devices descend from it; 3 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)
- K091470: Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059, Smith & Nephew, Inc. (2009) Summary page 1.

## Most influential descendants
- K132446: Renasys EZ Max Negative Pressure Wound Therapy Device (2013), 13 descendants of its own
- 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

## Recalls of this device
- Jul 18, 2014 · Class II · Z-0040-2015: RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.
- Jul 18, 2014 · Class II · Z-0041-2015: RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.
- Jul 18, 2014 · Class II · Z-0039-2015: RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.

## Indications for use
The RENASYS EZ PLUS 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 dehisced wounds * Ulcers (such as pressure or diabetic) * Partial-thickness burns * Flaps and grafts

Source page: https://510kreport.com/device/K102001
Methodology: https://510kreport.com/methodology