# K040358: Xltek Protektor Stimulator, Models 10247 & 10248

- Pathway: 510(k) (Traditional)
- Applicant: Excel Tech., Ltd.
- Decided: Aug 6, 2004 after 175 days
- Product code: GWF (Stimulator, Electrical, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1870
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Jan 2, 2015 · Class II · Z-1068-2015: Software error occurs when using remote monitoring; if the remote user tries to stop the free run waveform group, the system will display a message informing the user that they do not have sufficient 

## Indications for use
The Protektor Stimulator is intended to be used for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.

Source page: https://510kreport.com/device/K040358
Methodology: https://510kreport.com/methodology