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THE TAPE

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 / K252024

510(k) cleared

NeurAxis IB-Stim (01-1020)

Neuraxis · Oct 16, 2025 · K252024

FDA cleared the NeurAxis IB-Stim (01-1020) from Neuraxis on Oct 16, 2025 under K252024, a traditional 510(k). The device falls under product code QHH, Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs), regulated at 21 CFR 876.5340 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jun 30, 2025. The decision came 108 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 Neuraxis in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252024?

K252024 is the FDA 510(k) for NeurAxis IB-Stim (01-1020), submitted by Neuraxis. FDA's decision date was Oct 16, 2025, under product code QHH (Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)).

Who makes the NeurAxis IB-Stim (01-1020)?

Neuraxis, based in Carmel, IN, is the applicant of record for K252024.

How long did the K252024 review take?

FDA received the submission on Jun 30, 2025 and issued its decision on Oct 16, 2025, 108 days later.

← All decisions in October 2025