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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 / June 2026 / K253301

510(k) cleared

BraiN20® (BraiN20)

Time IS Brain, S.L. · Jun 27, 2026 · K253301

FDA cleared the BraiN20® (BraiN20) from Time IS Brain, S.L. on Jun 27, 2026 under K253301, a traditional 510(k). The device falls under product code GWF, Stimulator, Electrical, Evoked Response, regulated at 21 CFR 882.1870 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Sep 29, 2025. The decision came 271 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 Time IS Brain, S.L. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253301?

K253301 is the FDA 510(k) for BraiN20® (BraiN20), submitted by Time IS Brain, S.L.. FDA's decision date was Jun 27, 2026, under product code GWF (Stimulator, Electrical, Evoked Response).

Who makes the BraiN20® (BraiN20)?

Time IS Brain, S.L., based in Badalona, is the applicant of record for K253301.

How long did the K253301 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Jun 27, 2026, 271 days later.

← All decisions in June 2026