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Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

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 / January 2026 / K253925

510(k) cleared

Aventus Thrombectomy System

Inquis Medical · Jan 15, 2026 · K253925 · In the directory

FDA cleared the Aventus Thrombectomy System from Inquis Medical on Jan 15, 2026 under K253925, a traditional 510(k). The device falls under product code QEZ, Aspiration Thrombectomy Catheter, regulated at 21 CFR 870.5150 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 8, 2025. The decision came 38 days later, inside the 90 FDA-day goal for a 510(k).

Inquis Medical has 3 other decisions in the tracker over the last 12 months: K261105 (Powered Aventus Thrombectomy System), K262030 (Aventus Thrombectomy System), K260091 (Aventus Introducer Sheath).

Questions & Answers

What did FDA clear under K253925?

K253925 is the FDA 510(k) for Aventus Thrombectomy System, submitted by Inquis Medical. FDA's decision date was Jan 15, 2026, under product code QEZ (Aspiration Thrombectomy Catheter).

Who makes the Aventus Thrombectomy System?

Inquis Medical, based in Menlo Park, CA, is the applicant of record for K253925. The company is listed in the MedDevice Startups directory.

How long did the K253925 review take?

FDA received the submission on Dec 8, 2025 and issued its decision on Jan 15, 2026, 38 days later.

← All decisions in January 2026

Sources

In the startup directory

Inquis Medical

Cardiovascular · Menlo Park, CA