# K161418: Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set

- Pathway: 510(k) (Traditional)
- Applicant: Cardinalhealth
- Decided: Jan 19, 2017 after 241 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: 7 generations back to K945062 (1995). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150124: Cardinal Health NPWT PRO HC, Cardinalhealth (2015) Summary page 4.

## Most influential descendants
- K261338: RENASYS DYNAFLOW Kit (66807741) (2026), 0 descendants of its own

## Indications for use
The Cardinal Health NPWT Irrigation Tubing Set and Delivery Set are intended for use with the Cardinal Health NPWT SVED, PRO Family and PRO HC devices, which are indicated for the application of continual or intermittent negative pressure wound therapy to the wound as the device may promote wound healing by the removal of fluid including wound exudates, irrigation fluids, body fluids and infectious materials. The NPWT system is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The NPWT system is intended for use in acute, extended and home care settings, however wound irrigation is not intended for use in a home care setting.

Source page: https://510kreport.com/device/K161418
Methodology: https://510kreport.com/methodology