# K251826: RENASYS WOUND+  Dressing Kit with AIRLOCK Technology

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Medical, Ltd.
- Decided: Sep 11, 2025 after 90 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: 11 generations back to K945062 (1995). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243576: RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port, Smith & Nephew Medical, Ltd. (2025) Summary page 5.

## Indications for use
The RENASYS WOUND+ Dressing Kit with AIRLOCK Technology is intended to be used in conjunction with Smith+Nephew traditional Negative Pressure Wound Therapy (tNPWT) RENASYS systems. The Smith+Nephew RENASYS NPWT system is indicated for patients who would benefit from a suction pump (Negative Pressure Wound Therapy), as it allows for wound management via removal of fluids, including irrigation and body fluids, wound exudates and infectious materials. Appropriate wound types for RENASYS WOUND+ Dressing include: • Chronic • Acute • Traumatic • Sub-Acute and dehisced wounds • Ulcers (such as pressure or diabetic) • Partial-thickness burns • Flaps • Grafts RENASYS WOUND+ Dressing without filler can be used on the following additional wound type: • Closed surgical incisions The RENASYS WOUND+ Dressing Kit with AIRLOCK Technology in Small, Medium, and Large sizes is intended to be used with Smith+Nephew RENASYS TOUCH, RENASYS GO, and RENASYS EDGE NPWT systems.

Source page: https://510kreport.com/device/K251826
Methodology: https://510kreport.com/methodology