# K991900: Xltek Polysomnography Headbox, Model # PSG-40

- Pathway: 510(k) (Traditional)
- Applicant: Excel Tech., Ltd.
- Decided: Jul 12, 1999 after 38 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.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices 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.

## Most influential descendants
- K062533: Bwii Eeg Digital, Model PV 1652; Bwii PSG Digital, Model PV 1524 (2006), 1 descendant of its own
- K112107: Bwiii Eeg, Bwiii Eeg Plus, Bwiii PSG, Bwiii PSG Plus (2011), 0 descendants of its own
- K022037: Xltek Sleep System (2002), 0 descendants of its own

## Indications for use
The XLTek PSG-40 may be used for sleep recordings (polysomnography) in research or clinical environments for: o Digital recording of high-level output signals (such as EEG, respiratory and oximetry signals) from conventional polygraphic recorders, signal transducers or amplifiers e Selection of recorded signal sections for on-screen review, annotation annd marking of sleep stages Computer-assisted event marking and quantitative analysis of EEG, respiratory and oximetry signals Computer-assisted reporting of simple measures obtained from the recorded signals (such as magnitude, time and frequency and simple statistical measures of marked events) The PSG-40 is not intended to replace conventional devices or methods used for sleep monitoring in critical care or intra-operative settings. The PSG-40 requires competent user input, and its output must be reviewed and interpreted by trained polysomnographers or neurologists who will exercise professional judgement in using this information. The PSG-40 does not make any judgement of normality or abnormality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.

Source page: https://510kreport.com/device/K991900
Methodology: https://510kreport.com/methodology