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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 / February 2026 / K251517

510(k) cleared

Encora X1

Encora, Inc. · Feb 5, 2026 · K251517

FDA cleared the Encora X1 from Encora, Inc. on Feb 5, 2026 under K251517, a traditional 510(k). The device falls under product code QBC, External Upper Limb Tremor Stimulator, regulated at 21 CFR 882.5897 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on May 16, 2025. The decision came 265 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 Encora, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251517?

K251517 is the FDA 510(k) for Encora X1, submitted by Encora, Inc.. FDA's decision date was Feb 5, 2026, under product code QBC (External Upper Limb Tremor Stimulator).

Who makes the Encora X1?

Encora, Inc., based in Boston, MA, is the applicant of record for K251517.

How long did the K251517 review take?

FDA received the submission on May 16, 2025 and issued its decision on Feb 5, 2026, 265 days later.

← All decisions in February 2026