# K053386: Xltek EMU40 Eeg Headbox, Model PK1072

- Pathway: 510(k) (Traditional)
- Applicant: Excel Tech., Ltd.
- Decided: Apr 21, 2006 after 137 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 K980214 (1998). 1 ancestor in all.
14 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980214: Excel Neuro  Works, Excel Tech., Ltd. (1998). Our reading of the summary gave “K980214}.” beside “510(k)”; FDA’s K980214 is the only number that fits it and carries the summary’s name for the device. Summary page 3.

## Most influential descendants
- K072382: Model I-2000 Monitor (2008), 12 descendants of its own
- K082886: Zoom-100DC (2009), 11 descendants of its own
- K092477: NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701 (2010), 6 descendants of its own
- K142834: DiscoverEEG System, Model DE-401 (2015), 5 descendants of its own
- K120485: Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT P (2012), 5 descendants of its own

## Indications for use
The EMU40 Headbox is an electroencephalograph that works in conjunction with XLTEK NeuroWorks software (FDA 510(k) #K980214}. The EMU40 Headbox is used to acquire, digitize, store and transmit physiological signals (such as EEG, pulse and oximetry signals) for EEG studies in research and clinical environments. The EMU40 Headbox requires competent user input, and its output must be reviewed and interpreted by trained medical professionals who will exercise professional judgment in using this information.

Source page: https://510kreport.com/device/K053386
Methodology: https://510kreport.com/methodology