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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 / September 2025 / K250777

510(k) cleared

Sonicaid Team3

Huntleigh Healthcare , Ltd. · Sep 19, 2025 · K250777

FDA cleared the Sonicaid Team3 from Huntleigh Healthcare , Ltd. on Sep 19, 2025 under K250777, a traditional 510(k). The device falls under product code HGM, System, Monitoring, Perinatal, regulated at 21 CFR 884.2740 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Mar 14, 2025. The decision came 189 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 Huntleigh Healthcare , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250777?

K250777 is the FDA 510(k) for Sonicaid Team3, submitted by Huntleigh Healthcare , Ltd.. FDA's decision date was Sep 19, 2025, under product code HGM (System, Monitoring, Perinatal).

Who makes the Sonicaid Team3?

Huntleigh Healthcare , Ltd., based in Cardiff, is the applicant of record for K250777.

How long did the K250777 review take?

FDA received the submission on Mar 14, 2025 and issued its decision on Sep 19, 2025, 189 days later.

← All decisions in September 2025