# K202217: Kendall NPWT Incision Management Device

- Pathway: 510(k) (Traditional)
- Applicant: Cardinalhealth
- Decided: Jun 4, 2021 after 302 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 KendallTM Negative Pressure Wound Therapy (NPWT) Incision Management Device, when used with a KendallTM NPWT Incision Management Dressing Kit, 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 system is intended for use in acute, extended and home care settings.

Source page: https://510kreport.com/device/K202217
Methodology: https://510kreport.com/methodology