# K053141: Neurosign Motor Nerve Monitor, Models Neurosign 400 & 800

- Pathway: 510(k) (Special)
- Applicant: The Magstim Company, Ltd.
- Decided: Dec 14, 2005 after 35 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K181559: Neurosign V4 Intraoperative Nerve Monitor (2018), 1 descendant of its own
- K203684: Neurosign V4 Intraoperative Nerve Monitor (2021), 0 descendants of its own

## Indications for use
To locate and identify cranial motor nerves during ENT and intra-cranial procedures.

Source page: https://510kreport.com/device/K053141
Methodology: https://510kreport.com/methodology