# K251646: extriCARE® 1000 Negative Pressure Wound Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Alleva Medical Devices
- Decided: Oct 3, 2025 after 127 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: 14 generations back to K945062 (1995). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213906: extriCARE 1000 Negative Pressure Wound Therapy System, Alleva Medical, Ltd. (2023) Summary page 5.

## Indications for use
The extriCARE® 1000 NPWT System is intended to generate negative pressure to remove wound exudates, infectious material, and tissue debris from the wound bed. The extriCARE® 1000 NPWT System is intended for use in wounds with low to moderate levels of exudate. Appropriate wound types include: • Chronic wounds • Acute wounds • Traumatic wounds • Subacute and dehisced wounds • Partial-thickness burns • Ulcer wounds (such as diabetic or pressure) • Flaps and grafts • Closed surgical incisions The extriCARE® 1000 NPWT System is intended for use in healthcare facilities. The extriCARE® 1000 NPWT System is intended for use with extriCARE® 1000 Bandage Dressings.

Source page: https://510kreport.com/device/K251646
Methodology: https://510kreport.com/methodology