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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / May 2026 / K254276

510(k) cleared

Lynx Aspiration Catheter System

QApel Medical, Inc. · May 7, 2026 · K254276

FDA cleared the Lynx Aspiration Catheter System from QApel Medical, Inc. on May 7, 2026 under K254276, a traditional 510(k). The device falls under product code NRY, Catheter, Thrombus Retriever, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 30, 2025. The decision came 128 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for QApel Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254276?

K254276 is the FDA 510(k) for Lynx Aspiration Catheter System, submitted by QApel Medical, Inc.. FDA's decision date was May 7, 2026, under product code NRY (Catheter, Thrombus Retriever).

Who makes the Lynx Aspiration Catheter System?

QApel Medical, Inc., based in Fremont, CA, is the applicant of record for K254276.

How long did the K254276 review take?

FDA received the submission on Dec 30, 2025 and issued its decision on May 7, 2026, 128 days later.

← All decisions in May 2026