# K202783: Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Medical Limited
- Decided: Jan 14, 2022 after 479 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: 10 generations back to K945062 (1995). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Smith & Nephew, Inc. (2015) Summary page 4.

## Indications for use
RENASYS-F Foam dressing kits with Soft Port and RENASYS Films are intended to be used in conjunction with Smith & Nephew RENASYS Negative Pressure Wound Therapy (NPWT) Systems. The Smith & Nephew RENASYS system is indicated for patients who would benefit from a suction pump (Negative Pressure Wound Therapy), as it may promote wound healing via removal of fluids, including irrigation and body fluids, wound exudates 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

Source page: https://510kreport.com/device/K202783
Methodology: https://510kreport.com/methodology