# K181354: 074 Zenith Flex System

- Pathway: 510(k) (Traditional)
- Applicant: Inneuroco, Inc.
- Decided: Oct 25, 2018 after 156 days
- Product code: NRY (Catheter, Thrombus Retriever)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K003410 (2001). 13 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172167: Zenith Flex System, Inneuroco, Inc. (2018) Summary page 5.

## Most influential descendants
- K190212: AXS Vecta Aspiration System (2019), 5 descendants of its own
- K191768: AXS Vecta Aspiration System (2019), 4 descendants of its own
- K243601: Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set (2025), 2 descendants of its own
- K253590: Millipede System (2026), 1 descendant of its own
- K261089: Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit (2026), 0 descendants of its own

## Recalls of this device
- Apr 10, 2019 · Class II · Z-1621-2020: The firm has become aware of a potential problem that their Catheters may break/fracture and/or kink/bend if improperly removed from the packaging/dispenser hoop or during catheter use.

## Indications for use
The Zenith Flex System, including the Zenith Flex Catheter, Aspiration Tubing Set, and VC-701 Cliq Aspirator Pump, is indicated in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.

Source page: https://510kreport.com/device/K181354
Methodology: https://510kreport.com/methodology