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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 / K252504

510(k) cleared

Gastric Alimetry

Alimetry , Ltd. · Dec 5, 2025 · K252504

FDA cleared the Gastric Alimetry from Alimetry , Ltd. on Dec 5, 2025 under K252504, a traditional 510(k). The device falls under product code MYE, System, Electrogastrography (Egg), regulated at 21 CFR 876.1735 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Aug 8, 2025. The decision came 119 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 Alimetry , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252504?

K252504 is the FDA 510(k) for Gastric Alimetry, submitted by Alimetry , Ltd.. FDA's decision date was Dec 5, 2025, under product code MYE (System, Electrogastrography (Egg)).

Who makes the Gastric Alimetry?

Alimetry , Ltd., based in Auckland, is the applicant of record for K252504.

How long did the K252504 review take?

FDA received the submission on Aug 8, 2025 and issued its decision on Dec 5, 2025, 119 days later.

← All decisions in December 2025