# K112784: Renasys AB Abominal Dressing Kit

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Nov 22, 2011 after 57 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K945062 (1995). 14 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100787: Renasys F/-AB Abdominal Wound Dressing Kit, Smith & Nephew, Inc. (2010) Summary page 1.
- K110647: Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT Wound Dressing Kits with Suction Pad; Renasys, Smith & Nephew, Inc. (2011) Summary page 1.

## Most influential descendants
- K143133: RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing Kit with Soft Port Device (2015), 5 descendants of its own
- K181822: RENASYS Touch; RENASYS Y-Connector (2019), 3 descendants of its own
- K130852: Avance® Foam Abdominal Dressing Kit (2014), 3 descendants of its own
- K223041: Renasys Edge (66803126) (2022), 2 descendants of its own
- K231939: Renasys Edge (2024), 1 descendant of its own

## Indications for use
The RENASYS AR Abdominal Kit with.Soft Port 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 RENASYS AR Abdominal Kit with Soft Port is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.

Source page: https://510kreport.com/device/K112784
Methodology: https://510kreport.com/methodology