# K923056: Neurosign Model 100

- Pathway: 510(k) (Traditional)
- Applicant: The Magstim Company, Ltd.
- Decided: Nov 24, 1992 after 153 days
- Product code: ETN (Stimulator, Nerve)
- Device class: 2
- Regulation: 21 CFR 874.1820
- 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.
45 later devices descend from it; 1 cites it directly.
0 of 46 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
- K991583: Neurosign 400, 4 Channel Motor Nerve Monitor (1999), 44 descendants of its own
- K050325: Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar Probe (2005), 38 descendants of its own
- K062996: Disposable Monopolar and Bipolar Stimulator Probes (2007), 32 descendants of its own
- K090838: Stimulus/Dissection Instruments (2009), 19 descendants of its own
- K063729: Disposable Pedicle Screw Probe, Model 3603-00 (2007), 19 descendants of its own

## Recalls of this device
- Dec 8, 2020 · Class II · Z-0869-2021: A small number of Neurosign 100 Intraoperative Nerve Monitors may have been dispatched without being configured appropriately for the supply mains within the target Country. The specific deficiency in

Source page: https://510kreport.com/device/K923056
Methodology: https://510kreport.com/methodology