# K223041: Renasys Edge (66803126)

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Medical Limited
- Decided: Nov 22, 2022 after 54 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: 12 generations back to K945062 (1995). 31 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181822: RENASYS Touch; RENASYS Y-Connector, Smith & Nephew Medical Limited (2019) Summary page 4.

## Most influential descendants
- K231939: Renasys Edge (2024), 1 descendant of its own
- K260646: Renasys Edge (66803126) (2026), 0 descendants of its own

## Recalls of this device
- Oct 2, 2024 · Class II · Z-0516-2025: Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.
- Mar 11, 2024 · Class II · Z-1596-2024: Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
- Mar 11, 2024 · Class II · Z-1597-2024: Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump

## Indications for use
The RENASY'S EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids and body fluids, wound exudate 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 Grafts When used with the RENASYS AB Abdominal Kit with Soft Port, the RENASYS EDGE pump is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary. It is intended to be used in open abdominal wounds with exposed viscera, including but not limited to abdominal compartment syndrome. The use of RENASYS AB Abdominal Kit with Soft Port is intended for use in acute hospital care settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.

Source page: https://510kreport.com/device/K223041
Methodology: https://510kreport.com/methodology