FDA cleared the Report Studio from Beacon Biosignals, Inc. on Aug 25, 2026 under K261747, a traditional 510(k). The device falls under product code OLV, Standard Polysomnograph With Electroencephalograph, regulated at 21 CFR 882.1400 as a Class 2 device. The review panel was Neurology.
FDA logged the submission as received on May 27, 2026. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).
This is the only decision on file for Beacon Biosignals, Inc. in the last 12 months of the tracker.
Questions & Answers
What did FDA clear under K261747?
K261747 is the FDA 510(k) for Report Studio, submitted by Beacon Biosignals, Inc.. FDA's decision date was Aug 25, 2026, under product code OLV (Standard Polysomnograph With Electroencephalograph).
Who makes the Report Studio?
Beacon Biosignals, Inc., based in Boston, MA, is the applicant of record for K261747. The company is listed in the MedDevice Startups directory.
How long did the K261747 review take?
FDA received the submission on May 27, 2026 and issued its decision on Aug 25, 2026, 90 days later.