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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 / April 2026 / K254216

510(k) cleared

Enso for Migraine

Hinge Health, Inc. · Apr 16, 2026 · K254216

FDA cleared the Enso for Migraine from Hinge Health, Inc. on Apr 16, 2026 under K254216, a traditional 510(k). The device falls under product code PCC, Stimulator, Nerve, Electrical, Transcutaneous, For Migraine, regulated at 21 CFR 882.5891 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Dec 29, 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 Hinge Health, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254216?

K254216 is the FDA 510(k) for Enso for Migraine, submitted by Hinge Health, Inc.. FDA's decision date was Apr 16, 2026, under product code PCC (Stimulator, Nerve, Electrical, Transcutaneous, For Migraine).

Who makes the Enso for Migraine?

Hinge Health, Inc., based in San Francisco, CA, is the applicant of record for K254216.

How long did the K254216 review take?

FDA received the submission on Dec 29, 2025 and issued its decision on Apr 16, 2026, 108 days later.

← All decisions in April 2026