# K980148: Neurosign 800, 8 Channel Motor Nerve Monitor

- Pathway: 510(k) (Traditional)
- Applicant: The Magstim Company, Ltd.
- Decided: Aug 5, 1998 after 202 days
- Product code: ETN (Stimulator, Nerve)
- Device class: 2
- Regulation: 21 CFR 874.1820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
498 later devices descend from it; 4 cite it directly.
2 of 499 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
- K992869: Xomed Ball-Tip Monopolar Stimulator Probe (1999), 484 descendants of its own
- K063305: Stimulating Bur Guard (2006), 424 descendants of its own
- K111520: Ipc Powerease System (2011), 418 descendants of its own
- K124004: Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps (2013), 404 descendants of its own
- K123270: Powerease System (2013), 398 descendants of its own

## Indications for use
To locate and identify cranial and peripheral motor nerves during surgery, including spinal nerve roots.

Source page: https://510kreport.com/device/K980148
Methodology: https://510kreport.com/methodology