Lynx Aspiration Catheter System
FDA 510(k) K254276 · QApel Medical, Inc.
510(k) numberK254276
Submission
- Device name
- Lynx Aspiration Catheter System
- Applicant
- QApel Medical, Inc.
Fremont, CA, US - Received
- December 30, 2025
- Decision date
- May 7, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NRY – Catheter, Thrombus Retriever
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature. It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode.
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|---|---|---|---|
| K260617 | Tigertriever 13 Ultra Revascularization DeviceNRY · Traditional | Rapid Medical Ltd. | 08/28/2026SE |
| K262398 | CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setNRY · Special | CERENOVUS, Inc. | 08/13/2026SE |
| K262399 | Millipede SystemNRY · Special | Perfuze, Ltd. | 08/12/2026SE |
| K262391 | APRO 35 Swift Catheter and Alembic Aspiration TubingNRY · Special | Alembic, LLC | 08/12/2026SE |
| K260002 | Socrates Aspiration System (Socrates 70 Aspiration Catheter)NRY · Traditional | Scientia Vascular, Inc. | 07/16/2026SE |
| K250690 | Penumbra System (Thunderbolt Aspiration Tubing)NRY · Traditional | Penumbra, Inc. | 06/10/2026SE |
| K252707 | Zenith Aspiration Catheter; Disposable Aspiration Tubing SetNRY · Traditional | Suzhou Zenith Vascular SciTech Limited | 05/20/2026SE |
| K253590 | Millipede SystemNRY · Traditional | Perfuze, Ltd. | 03/16/2026SE |
| K253062 | Tigertriever 25 Revascularization DeviceNRY · Traditional | Rapid Medical Ltd. | 03/12/2026SE |
| K251357 | Esperance pHLO Aspiration SystemNRY · Traditional | Phenox, Ltd. | 01/15/2026SE |
More from Phenox, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K240746 | Neurovascular Access System FamilyQJP · Traditional | 11/20/2024SE |
| K222786 | 072 Aspiration SystemNRY · Traditional | 08/25/2023SE |
| K230322 | SelectFlex Neurovascular Access System FamilyQJP · Traditional | 06/22/2023SE |
| K211893 | SelectFlex Neurovascular Access System FamilyQJP · Special | 08/05/2021SE |
| K192525 | 087 Balloon Guide Catheter SystemDQY · Traditional | 10/31/2019SE |
| K191664 | SelectFlex 072 Neurovascular Access SystemDQY · Special | 08/30/2019SE |
Questions and answers
When was Lynx Aspiration Catheter System cleared by the FDA?
Lynx Aspiration Catheter System (K254276) received a 510(k) decision of Substantially Equivalent on May 7, 2026, 128 days after the submission was received.
What is the product code of K254276?
The FDA product code is NRY – Catheter, Thrombus Retriever, a Class II (moderate risk) device regulated under 21 CFR 870.1250.