# K222848: pRESET Thrombectomy Device

- Pathway: 510(k) (Traditional)
- Applicant: Phenox Limited
- Decided: Jan 20, 2023 after 121 days
- Product code: POL (Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment)
- Device class: 2
- Regulation: 21 CFR 882.5600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN150049 (2016). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162539: Solitaire 2 Revascularization Device, Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (2016) Summary page 4.

## Most influential descendants
- K231539: pRESET LITE Thrombectomy Device (2023), 1 descendant of its own
- K242676: pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device (2025), 0 descendants of its own

## Indications for use
1. The pRESET® Thrombectomy Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received thrombolytic therapy. Endovascular therapy with the device should be started within 6 hours of symptom onset. 2. The pRESET® Thrombectomy Device is indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for thrombolytic therapy or who fail thrombolytic therapy are candidates for treatment.

Source page: https://510kreport.com/device/K222848
Methodology: https://510kreport.com/methodology