# 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

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Medical, Ltd.
- Decided: Aug 4, 2016 after 273 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). 24 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 30 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.
- K142626: Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set, Y-connector, Drain Adaptor, Invia Liberty Canisters, Medela AG (2015) Summary page 4.

## Most influential descendants
- K181822: RENASYS Touch; RENASYS Y-Connector (2019), 3 descendants of its own
- 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
- K181204: RENASYS Y-Connector; RENASYS TOUCH (2019), 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 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 The RENASYS TOUCH is intended for use in acute care settings and other professional healthcare environments where product use is conducted by or under the supervision of a qualified healthcare professional.

Source page: https://510kreport.com/device/K153209
Methodology: https://510kreport.com/methodology