# K143016: Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home

- Pathway: 510(k) (Traditional)
- Applicant: Cardinalhealth
- Decided: Apr 20, 2015 after 182 days
- Product code: OMP (Negative Pressure Wound Therapy Powered Suction Pump)
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K945062 (1995). 7 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111333: Antlia Iii Wound Treatment System, Innovative Therapies, Inc. (2011) Summary page 4.

## Most influential descendants
- K150124: Cardinal Health NPWT PRO HC (2015), 3 descendants of its own
- K161418: Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set (2017), 1 descendant of its own
- K261338: RENASYS DYNAFLOW Kit (66807741) (2026), 0 descendants of its own
- K171499: Occlusion Detection Dressing Kit (2017), 0 descendants of its own

## Recalls of this device
- Jun 4, 2020 · Class II · Z-2544-2020: Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device.
- Jun 4, 2020 · Class II · Z-2543-2020: Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device.

## Indications for use
The Cardinal Health NPWT PRO/PRO to GO/PRO at Home systems are an integrated wound management system, 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 fluids, including wound exudates, irrigation fluids, body fluids and infectious materials. The systems are intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The systems are intended for use in acute, extended and home care settings.

Source page: https://510kreport.com/device/K143016
Methodology: https://510kreport.com/methodology