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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 / September 2025 / K251518

510(k) cleared

Volta AF-Xplorer II

Volta Medical · Sep 12, 2025 · K251518

FDA cleared the Volta AF-Xplorer II from Volta Medical on Sep 12, 2025 under K251518, a traditional 510(k). The device falls under product code DQK, Computer, Diagnostic, Programmable, regulated at 21 CFR 870.1425 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on May 16, 2025. The decision came 119 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 Volta Medical in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251518?

K251518 is the FDA 510(k) for Volta AF-Xplorer II, submitted by Volta Medical. FDA's decision date was Sep 12, 2025, under product code DQK (Computer, Diagnostic, Programmable).

Who makes the Volta AF-Xplorer II?

Volta Medical, based in Marseille, is the applicant of record for K251518.

How long did the K251518 review take?

FDA received the submission on May 16, 2025 and issued its decision on Sep 12, 2025, 119 days later.

← All decisions in September 2025