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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 / October 2025 / K250904

510(k) cleared

Atalante X

Wandercraft SAS · Oct 24, 2025 · K250904 · In the directory

FDA cleared the Atalante X from Wandercraft SAS on Oct 24, 2025 under K250904, a traditional 510(k). The device falls under product code PHL, Powered Exoskeleton, regulated at 21 CFR 890.3480 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Mar 26, 2025. The decision came 212 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Wandercraft SAS has one other decision in the tracker over the last 12 months: K260381 (Eve).

Questions & Answers

What did FDA clear under K250904?

K250904 is the FDA 510(k) for Atalante X, submitted by Wandercraft SAS. FDA's decision date was Oct 24, 2025, under product code PHL (Powered Exoskeleton).

Who makes the Atalante X?

Wandercraft SAS, based in Paris, is the applicant of record for K250904. The company is listed in the MedDevice Startups directory.

How long did the K250904 review take?

FDA received the submission on Mar 26, 2025 and issued its decision on Oct 24, 2025, 212 days later.

← All decisions in October 2025

Sources

In the startup directory

Wandercraft

Rehab & Mobility · Paris, France