# K191101: Kendall NPWT Incision Management Dressing Kit

- Pathway: 510(k) (Traditional)
- Applicant: Cardinalhealth
- Decided: Jul 31, 2020 after 463 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: 9 generations back to K945062 (1995). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180855: Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System, Kci USA, Inc. (2018) Summary page 4.

## Indications for use
The Kendall NPWT Incision Management Dressing Kit, when used with a Cardinal Health NPWT CATALYST, ALLY or ALLY TO GO Devices, is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy. The Cardinal Health NPWT CATALYST, ALLY, or ALLY TO GO System is intended for use in acute, extended and home care settings.

Source page: https://510kreport.com/device/K191101
Methodology: https://510kreport.com/methodology