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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 / March 2026 / K252893

510(k) cleared

ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013)

Aneuvo · Mar 27, 2026 · K252893

FDA cleared the ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013) from Aneuvo on Mar 27, 2026 under K252893, a traditional 510(k). The device falls under product code SDO, Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation, regulated at 21 CFR 890.5851 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Sep 11, 2025. The decision came 197 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 Aneuvo in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252893?

K252893 is the FDA 510(k) for ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013), submitted by Aneuvo. FDA's decision date was Mar 27, 2026, under product code SDO (Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation).

Who makes the ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013)?

Aneuvo, based in Los Angeles, CA, is the applicant of record for K252893.

How long did the K252893 review take?

FDA received the submission on Sep 11, 2025 and issued its decision on Mar 27, 2026, 197 days later.

← All decisions in March 2026