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THE TAPE

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 / November 2025 / K251070

510(k) cleared

Akura Thrombectomy System

Akura Medical · Nov 25, 2025 · K251070 · In the directory

FDA cleared the Akura Thrombectomy System from Akura Medical on Nov 25, 2025 under K251070, a traditional 510(k). The device falls under product code QEW, Peripheral Mechanical Thrombectomy With Aspiration, regulated at 21 CFR 870.5150 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Apr 7, 2025. The decision came 232 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 Akura Medical in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251070?

K251070 is the FDA 510(k) for Akura Thrombectomy System, submitted by Akura Medical. FDA's decision date was Nov 25, 2025, under product code QEW (Peripheral Mechanical Thrombectomy With Aspiration).

Who makes the Akura Thrombectomy System?

Akura Medical, based in Los Gatos, CA, is the applicant of record for K251070. The company is listed in the MedDevice Startups directory.

How long did the K251070 review take?

FDA received the submission on Apr 7, 2025 and issued its decision on Nov 25, 2025, 232 days later.

← All decisions in November 2025

Sources

In the startup directory

Akura Medical

Cardiovascular · Los Gatos, CA