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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 / K251368

510(k) cleared

FETOLY

Diagnoly · Sep 12, 2025 · K251368

FDA cleared the FETOLY from Diagnoly on Sep 12, 2025 under K251368, a traditional 510(k). The device falls under product code IYN, System, Imaging, Pulsed Doppler, Ultrasonic, regulated at 21 CFR 892.1550 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on May 1, 2025. The decision came 134 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 Diagnoly in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251368?

K251368 is the FDA 510(k) for FETOLY, submitted by Diagnoly. FDA's decision date was Sep 12, 2025, under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

Who makes the FETOLY?

Diagnoly, based in Lyon, is the applicant of record for K251368.

How long did the K251368 review take?

FDA received the submission on May 1, 2025 and issued its decision on Sep 12, 2025, 134 days later.

← All decisions in September 2025