# K082426: Renasys EZ

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Sep 5, 2008 after 14 days
- Product code: OMP (Negative Pressure Wound Therapy Powered Suction Pump)
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K945062 (1995). 5 ancestors in all.
58 later devices descend from it; 3 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061919: Versatile 1 Ezcare Wound Vacuum System, Blue Sky Medical Group Incorporated (2007) Summary page 1.

## Most influential descendants
- K083375: Renasys GO Negative Pressure Wound Therapy (2009), 56 descendants of its own
- K111170: PICO (2011), 26 descendants of its own
- K112127: Pico Single Use Negative Pressure Wound Therapy System (2012), 25 descendants of its own
- K151436: PICO Single Use Negative Pressure Wound Therapy System (2016), 23 descendants of its own
- K091470: Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059 (2009), 15 descendants of its own

## Recalls of this device
- Aug 13, 2014 · Class II · Z-2688-2014: Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification.
- 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 is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing.

Source page: https://510kreport.com/device/K082426
Methodology: https://510kreport.com/methodology