# K022037: Xltek Sleep System

- Pathway: 510(k) (Special)
- Applicant: Excel Tech., Ltd.
- Decided: Sep 10, 2002 after 78 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: 4 generations back to K962603 (1997). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991900: Xltek Polysomnography Headbox, Model # PSG-40, Excel Tech., Ltd. (1999) Summary page 2.
- K992340: Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop -Adt-Adult/Pediatric Disposable Sensor, Masimo Lnop -PDT-PE, Masimo Corp. (1999) Summary page 1.
- K000126: Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop-Adt-Adult/Pediatric Disposable Sensor, Masimo Lno-PDT-Pedia, Masimo Corp. (2000) Summary page 1.
- K982479: Excel Ambulatory Eeg, Excel Tech., Ltd. (1998) Summary page 1.

## Indications for use
The Sleep Headbox works in conjunction with Excel Tech Sleep software. This Sleep System is used to acquire and review sleep recordings (polysomnography) in rescarch or clinical environments for: Digital recording of high-level output signals (such as EEG, respiratory and oximetry signals) from conventional polygraphic recorders, signal transducers or amplifiers. Selection of recorded signal sections for on-screen review, annotation and marking of sleep stages. Computer-assisted event marking and quantitative analysis of EEG, respiratory and oximetry signals. Computer-assisted reporting of simple measurcs obtained from the recorded signals (such as magnitude, time and frequency and simple statistical measures of marked events) The SLEEP System is not intended to replace conventional devices or methods used for sleep monitoring in critical care or intraoperative settings. The SLEEP System requires competent user input, and its output must be revicwed and interpreted by trained polysomnographers or trained medical professionals who will exercise professional judgment in using this information. The SLEEP System does not make any judgment of normality or abnormality of the displayed signals or the result 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/K022037
Methodology: https://510kreport.com/methodology