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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 / P230024

PMA approved

Flow FL-100

Flow Neuroscience AB · Dec 8, 2025 · P230024 · In the directory

FDA approved the Flow FL-100 from Flow Neuroscience AB on Dec 8, 2025 under P230024, an original premarket approval. The device falls under product code JXK, Cranial Electrotherapy Stimulator To Treat Depression, regulated at 21 CFR 882.5800 as a Class 3 device. The review panel was Neurology.

FDA logged the submission as received on Aug 7, 2023. The decision came 854 days later.

This is the only decision on file for Flow Neuroscience AB in the last 12 months of the tracker.

Questions & Answers

What did FDA approve under P230024?

P230024 is the FDA PMA for Flow FL-100, submitted by Flow Neuroscience AB. FDA's decision date was Dec 8, 2025, under product code JXK (Cranial Electrotherapy Stimulator To Treat Depression).

Who makes the Flow FL-100?

Flow Neuroscience AB, based in Palo Alto, CA, is the applicant of record for P230024. The company is listed in the MedDevice Startups directory.

How long did the P230024 review take?

FDA received the submission on Aug 7, 2023 and issued its decision on Dec 8, 2025, 854 days later.

← All decisions in December 2025