# K992313: XL Tek Evoked Potential Headbox, Model EP-16

- Pathway: 510(k) (Traditional)
- Applicant: Excel Tech., Ltd.
- Decided: Aug 19, 1999 after 41 days
- Product code: GWF (Stimulator, Electrical, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K091963: Vigilant Eeg Monitor, Vigilant 2.0 (2009), 0 descendants of its own

## Indications for use
The EP-16 is intended for use in the operating room and critical care areas for neurological monitoring and assessment. The instrument uses EEG, evoked potentials, and EMG techniques to provide the health professionals with information to help assess a patient’s neurological status during surgery or long term monitoring in the ICU.

Source page: https://510kreport.com/device/K992313
Methodology: https://510kreport.com/methodology