# K010092: Xltek Evoked Potential Headbox, Model Real Patient EP-8-RP (Proposed)

- Pathway: 510(k) (Traditional)
- Applicant: Excel Tech., Ltd.
- Decided: Apr 2, 2001 after 81 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.
3 later devices descend from it; 1 cites 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 has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K011794: Xltek Led Goggles, Model Led-01 (2001), 2 descendants of its own
- K113785: Adherent Visual Stimulator Goggles (2012), 1 descendant of its own
- K200705: Nurochek System (2020), 0 descendants of its own

Source page: https://510kreport.com/device/K010092
Methodology: https://510kreport.com/methodology