# K261338: RENASYS DYNAFLOW Kit (66807741)

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Medical, Ltd.
- Decided: Sep 11, 2026 after 141 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: 8 generations back to K945062 (1995). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161418: Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set, Cardinalhealth (2017) Summary page 5.
- K203316: V.A.C.ULTA Negative Pressure Wound Therapy System, Kci, A Part of 3M Health Care Business Group (2021) Summary page 5.

## Indications for use
The RENASYS DYNAFLOW system is intended to be used in conjunction with Smith + Nephew RENASYS EDGE and RENASYS TOUCH NPWT for the application of negative pressure wound therapy to the wound to promote wound management by the delivery of saline to the wound bed and removal of fluids (including saline, irrigation fluids, body fluids, wound exudates and infectious material). For patients who would benefit from vacuum assisted drainage and controlled delivery of saline over the wound bed. The RENASYS DYNAFLOW device is intended for use in the clinical setting by clinicians. Appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure and diabetic), partial-thickness burns, flaps, and grafts.

Source page: https://510kreport.com/device/K261338
Methodology: https://510kreport.com/methodology