# K221223: extriCARE® 3000 Negative Wound Pressure Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Alleva Medical Devices
- Decided: Feb 9, 2023 after 287 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: 8 generations back to K945062 (1995). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132225: Extricare, Devon Medical, Inc. (2014) Summary page 4.

## Indications for use
The extriCARE® 3000 Negative Pressure Wound Therapy System is intended to generate negative pressure or suction to remove wound exudates, infectious material, and tissue debris from the wound bed. It is indicated for the following wound types: • chronic • acute • traumatic • subacute and dehisced wounds • partial-thickness burns • ulcers (such as diabetic or pressure) • flaps and grafts. The extriCARE® 3000 Negative Pressure Wound Therapy System is intended for use in healthcare facilities.

Source page: https://510kreport.com/device/K221223
Methodology: https://510kreport.com/methodology