# K091470: Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 9, 2009 after 52 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: 6 generations back to K945062 (1995). 17 ancestors in all.
15 later devices descend from it; 1 cites 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)
- K082426: Renasys EZ, Smith & Nephew, Inc. (2008) Summary page 1.
- K083375: Renasys GO Negative Pressure Wound Therapy, Smith & Nephew, Inc. (2009) Summary page 1.

## Most influential descendants
- K102001: Modification to Renasys EZ Plus Negative Pressure Wound Therapy (2010), 14 descendants of its own
- 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

## Recalls of this device
- Jan 29, 2010 · Not classified · Z-0310-2011: Smith&Nephew Inc., Advance Wound Management, St Petersburg, FL is recalling their Ezcare Negative Pressure Wound Therapy pumps manufactured by BlueSky Medical Group Inc., between July 17, 2007 and Dec

## Indications for use
The Renasys EZ is indicated for patients who would benefit from a suction device (negative pressure) as it may promote wound healing via the 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/K091470
Methodology: https://510kreport.com/methodology