# K213853: RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large

- Pathway: 510(k) (Traditional)
- Applicant: Smith and Nephew Medical Limited
- Decided: Feb 10, 2023 after 427 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: 3 generations back to K100821 (2010). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133276: V.a.C. Granufoam Dressing, Granufoam Thin Dressing, Granufoam Round Dressing, Granufoam Silver Dressing, Whitefoam Dress, Kci USA, Inc. (2013) Summary page 4.

## Most influential descendants
- K250586: Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory (2025), 0 descendants of its own

## Indications for use
The RENASYS White Foam NPWT Dressing is a moist, sterile, polyvinyl alcohol (PVA) foam intended to be used in conjunction with Smith & Nephew RENASYS TOUCH and RENASYS GO 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 the removal of wound fluids, including irrigation of 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/K213853
Methodology: https://510kreport.com/methodology