# K254276: Lynx Aspiration Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Q’Apel Medical, Inc.
- Decided: May 7, 2026 after 128 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). 20 ancestors in all.
No later device cites it as a predicate yet.
1 of 21 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242104: Penumbra System (Reperfusion Catheter RED 72), Penumbra, Inc. (2025) Summary page 5.
- K203440: Penumbra System (Reperfusion Catheter RED 62), Penumbra, Inc. (2021) Summary page 5.
- K222808: Penumbra System (Reperfusion Catheter RED 43), Penumbra, Inc. (2022) Summary page 5.

## Indications for use
The Lynx Aspiration Catheter with the Aspiration Tubing and a compatible suction 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, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who fail thrombolytic drug therapy are candidates for treatment. The Aspiration Tubing is indicated to connect the Lynx Aspiration Catheter to the compatible suction pump.

Source page: https://510kreport.com/device/K254276
Methodology: https://510kreport.com/methodology