# K243601: Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set

- Pathway: 510(k) (Traditional)
- Applicant: Route 92 Medical, Inc.
- Decided: May 19, 2025 after 179 days
- Product code: NRY (Catheter, Thrombus Retriever)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K003410 (2001). 16 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191768: AXS Vecta Aspiration System, Stryker Neurovascular (2019) Summary page 5.

## Most influential descendants
- K253590: Millipede System (2026), 1 descendant of its own
- K262399: Millipede System (2026), 0 descendants of its own

## Indications for use
The Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set, when used with a compatible vacuum pump, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within the internal carotid artery and middle cerebral artery M1 segment within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.

Source page: https://510kreport.com/device/K243601
Methodology: https://510kreport.com/methodology