# K261747: Report Studio

- Pathway: 510(k) (Traditional)
- Applicant: Beacon Biosignals, Inc.
- Decided: Aug 25, 2026 after 90 days
- Product code: OLV (Standard Polysomnograph With Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K962603 (1997). 43 ancestors in all.
No later device cites it as a predicate yet.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241288: Noxturnal Web, Nox Medical Ehf (2024) Summary page 5.

## Indications for use
Report Studio is a web-based software-only medical device indicated for use in diagnostic evaluation by qualified healthcare professionals to assess sleep quality and as an aid for the diagnosis of sleep and respiratory-related disorders. Report Studio supports the display, review, and manual scoring of physiological recordings containing cardiopulmonary, electroencephalographic (EEG), and/or other polysomnographic (PSG) signals. Report Studio supports display and user adjudication of recording metadata and annotations, can report basic statistical information regarding such content, and can aid in the generation of summary reports from user input, but does not itself independently provide automated sleep staging or similar capabilities.

Source page: https://510kreport.com/device/K261747
Methodology: https://510kreport.com/methodology