# K260646: Renasys Edge (66803126)

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Medical, Ltd.
- Decided: May 27, 2026 after 89 days
- Product code: OMP (Negative Pressure Wound Therapy Powered Suction Pump)
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K945062 (1995). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231939: Renasys Edge, Smith & Nephew Medical, Ltd. (2024) Summary page 6.

## Indications for use
The RENASYS™ EDGE Pump is indicated for patients who would benefit from a suction pump (NPWT), as it allows for wound management 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 The RENASYS™ EDGE Pump is compatible with the following: • RENASYS™ Foam Dressing Kits • RENASYS™ Foam Dressing Kit - XL • RENASYS™ Gauze Dressing Kits • RENASYS™ Abdominal Dressing Kit • RENASYS™ Y Connector Kit • RENASYS™ White Foam Wound Dressing • RENASYS™ WOUND+ Dressing Kit with AIRLOCK Technology When used with the RENASYS™ WOUND+ Dressing Kit without filler, the RENASYS™ EDGE pump is indicated for the following additional wound type: • Closed surgical incisions Important information when using the RENASYS™ AB Abdominal Kit with Soft Port. 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/K260646
Methodology: https://510kreport.com/methodology