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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 / K253767

510(k) cleared

UB ERP System

Universal Brain · Jun 30, 2026 · K253767

FDA cleared the UB ERP System from Universal Brain on Jun 30, 2026 under K253767, a traditional 510(k). The device falls under product code OLT, Non-Normalizing Quantitative Electroencephalograph Software, regulated at 21 CFR 882.1400 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Nov 25, 2025. The decision came 217 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 Universal Brain in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253767?

K253767 is the FDA 510(k) for UB ERP System, submitted by Universal Brain. FDA's decision date was Jun 30, 2026, under product code OLT (Non-Normalizing Quantitative Electroencephalograph Software).

Who makes the UB ERP System?

Universal Brain, based in Palo Alto, CA, is the applicant of record for K253767.

How long did the K253767 review take?

FDA received the submission on Nov 25, 2025 and issued its decision on Jun 30, 2026, 217 days later.

← All decisions in June 2026