FDA cleared the SMARTVERTIGO Vestibular Assessment System from VertigoDx, Inc. on Jul 30, 2026 under K260566, a traditional 510(k). The device falls under product code GWN, Nystagmograph, regulated at 21 CFR 882.1460 as a Class 2 device. The review panel was Neurology.
FDA logged the submission as received on Feb 19, 2026. The decision came 161 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 VertigoDx, Inc. in the last 12 months of the tracker.
Questions & Answers
What did FDA clear under K260566?
K260566 is the FDA 510(k) for SMARTVERTIGO Vestibular Assessment System, submitted by VertigoDx, Inc.. FDA's decision date was Jul 30, 2026, under product code GWN (Nystagmograph).
Who makes the SMARTVERTIGO Vestibular Assessment System?
VertigoDx, Inc., based in Wilmington, DE, is the applicant of record for K260566. The company is listed in the MedDevice Startups directory.
How long did the K260566 review take?
FDA received the submission on Feb 19, 2026 and issued its decision on Jul 30, 2026, 161 days later.