# K171499: Occlusion Detection Dressing Kit

- Pathway: 510(k) (Traditional)
- Applicant: Cardinalhealth
- Decided: Sep 22, 2017 after 122 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.
No later device cites it as a predicate yet.
0 of 10 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.

## Indications for use
The Cardinal Health NPWT device is an integrated wound management system, indicated for the application of continual or intermittent negative pressure wound therapy. The system may promote wound healing by the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious materials. The 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 system is intended for use in acute, extended and home care settings.

Source page: https://510kreport.com/device/K171499
Methodology: https://510kreport.com/methodology