# K260585: Noxturnal Web

- Pathway: 510(k) (Special)
- Applicant: Nox Medical Ehf
- Decided: Mar 20, 2026 after 28 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
Noxturnal Web is intended to be used for the diagnostic evaluation by a physician to assess sleep quality and as an aid for the diagnosis of sleep and respiratory-related sleep disorders in adults (18 years and above). Noxturnal Web is a software-only medical device to be used to analyze physiological signals and manually score sleep study results, including the staging of sleep, AHI, and detection of sleep disordered breathing events including obstructive apneas. It is intended to be used under the supervision of a clinician in a clinical environment.

Source page: https://510kreport.com/device/K260585
Methodology: https://510kreport.com/methodology