# K181822: RENASYS Touch; RENASYS Y-Connector

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Medical Limited
- Decided: Mar 21, 2019 after 255 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). 30 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153209: RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters,  RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply, Smith & Nephew Medical, Ltd. (2016) Summary page 6.
- K143133: RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing Kit with Soft Port Device, Smith & Nephew, Inc. (2015) Summary page 6.

## Most influential descendants
- K223041: Renasys Edge (66803126) (2022), 2 descendants of its own
- K231939: Renasys Edge (2024), 1 descendant of its own
- K260646: Renasys Edge (66803126) (2026), 0 descendants of its own

## Indications for use
RENASYS TOUCH is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy), as it may promote wound healing via removal of fluids, including irrigation fluids 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 and grafts When used with the RENASYS AB Abdominal Kit with Soft Port, RENASYS TOUCH 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 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. The RENASYS Y-Connector can only be used with the RENASYS TOUCH system. RENASYS TOUCH is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of fluids, including irrigation and body fluids, wound exudates and infectious materials. The following wound types may be used with a RENASYS system that is utilizing a RENASYS Y-connector: • Flaps and grafts (only in one wound configuration) • Open abdomen (only in one wound configuration & only with RENASYS TOUCH and RENASYS AB Abdominal Kit) • Chronic • Acute • Traumatic • Sub-Acute and dehisced wounds • Ulcers (such as pressure or diabetic) • Partial-thickness burns When the RENASYS Y-Connector is used with the RENASYS AB Abdominal Kit with Soft Port (only in one wound configuration), it 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 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/K181822
Methodology: https://510kreport.com/methodology