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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 / December 2025 / K252187

510(k) cleared

Aura Glide (FC40)

Aura Medical, LLC · Dec 23, 2025 · K252187

FDA cleared the Aura Glide (FC40) from Aura Medical, LLC on Dec 23, 2025 under K252187, a traditional 510(k). The device falls under product code NFO, Stimulator, Transcutaneous Electrical, Aesthetic Purposes, regulated at 21 CFR 882.5890 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Jul 14, 2025. The decision came 162 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 Aura Medical, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252187?

K252187 is the FDA 510(k) for Aura Glide (FC40), submitted by Aura Medical, LLC. FDA's decision date was Dec 23, 2025, under product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes).

Who makes the Aura Glide (FC40)?

Aura Medical, LLC, based in Brooklyn, NY, is the applicant of record for K252187.

How long did the K252187 review take?

FDA received the submission on Jul 14, 2025 and issued its decision on Dec 23, 2025, 162 days later.

← All decisions in December 2025