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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 / October 2025 / K243727

510(k) cleared

Re:Balans

Mode Sensors AS · Oct 16, 2025 · K243727

FDA cleared the Re:Balans from Mode Sensors AS on Oct 16, 2025 under K243727, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code DSB, Plethysmograph, Impedance, regulated at 21 CFR 870.2770 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 3, 2024. The decision came 317 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 Mode Sensors AS in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K243727?

K243727 is the FDA 510(k) for Re:Balans, submitted by Mode Sensors AS. FDA's decision date was Oct 16, 2025, under product code DSB (Plethysmograph, Impedance).

Who makes the Re:Balans?

Mode Sensors AS, based in Trondheim, is the applicant of record for K243727.

How long did the K243727 review take?

FDA received the submission on Dec 3, 2024 and issued its decision on Oct 16, 2025, 317 days later.

← All decisions in October 2025