# K131266: Trez_HD

- Pathway: 510(k) (Traditional)
- Applicant: Excel-Tech Ltd. (Xltek)
- Decided: Feb 14, 2014 after 287 days
- Product code: GWQ (Full-Montage Standard 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: 1 generation back to K042150 (2004). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042150: Xltek Trex Model#10309, Excel Tech., Ltd. (2004) Summary page 1.

## Most influential descendants
- K162595: Trex_HD (2016), 0 descendants of its own

## Indications for use
The Trex HD is an Electroencephalograph intended to be used to acquire, display, store and archive electroencephalographic signals, intended for electroencephalographic (EEG) or level 1-2 polysomnographic (PSG) recordings. The Trex HD amplifier is designed to be used with Natus NeuroWorksTM or Natus SleepWorksTM software.

Source page: https://510kreport.com/device/K131266
Methodology: https://510kreport.com/methodology