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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 / March 2026 / K260455

510(k) cleared

New Wave System

Zeto, Inc. · Mar 13, 2026 · K260455

FDA cleared the New Wave System from Zeto, Inc. on Mar 13, 2026 under K260455, a special 510(k). The device falls under product code GWQ, Full-Montage Standard Electroencephalograph, regulated at 21 CFR 882.1400 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Feb 11, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Zeto, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260455?

K260455 is the FDA 510(k) for New Wave System, submitted by Zeto, Inc.. FDA's decision date was Mar 13, 2026, under product code GWQ (Full-Montage Standard Electroencephalograph).

Who makes the New Wave System?

Zeto, Inc., based in Raleigh, NC, is the applicant of record for K260455.

How long did the K260455 review take?

FDA received the submission on Feb 11, 2026 and issued its decision on Mar 13, 2026, 30 days later.

← All decisions in March 2026