# K022249: Nightron Polysomnography System

- Pathway: 510(k) (Traditional)
- Applicant: Telediagnostic Systems, Inc.
- Decided: Dec 31, 2002 after 172 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This is a diagnostic device for use upon the order of a physician and under the supervision of qualified health care professional. The device is used in the assessment of sleep related disorders by recording a range of physiologic parameters during sleep. These parameters are presented graphically on a computer screen for diagnostic review, similar in application to the use of a traditional paper based polygraph recorder. This device does not provide alarms, is not intended for use as an automated apnea monitor, and does not provide automated diagnostic analysis.

Source page: https://510kreport.com/device/K022249
Methodology: https://510kreport.com/methodology