# K251070: Akura Thrombectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Akura Medical
- Decided: Nov 25, 2025 after 232 days
- Product code: QEW (Peripheral Mechanical Thrombectomy With Aspiration)
- Device class: 2
- Regulation: 21 CFR 870.5150
- 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 K003410 (2001). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192981: Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12, Penumbra, Inc. (2020) Summary page 5.

## Indications for use
The Akura Thrombectomy Catheter System As part of the Akura Thrombectomy System, the Akura Thrombectomy Catheter System is indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems. The Akura Thrombectomy Accessory Kit As part of the Akura Thrombectomy System, the Akura Accessory Kit is indicated to connect the Akura Thrombectomy Catheter to the Akura Thrombectomy Console. The Akura Thrombectomy Console The Akura Thrombectomy Console is indicated as a vacuum source for the Akura Thrombectomy System.

Source page: https://510kreport.com/device/K251070
Methodology: https://510kreport.com/methodology