# K162873: MEP Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Tonica Elektronik A/S
- Decided: Mar 31, 2017 after 169 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
Longest line of descent: 4 generations back to K905059 (1991). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051864: Magstim RAPID2, Magstim Super RAPID2, Models 3004-000, 3005-00, The Magstim Company, Ltd. (2005) Summary page 4.
- K061645: Magpro, Model R30, Tonica Elektronik A/S (2006) Summary page 4.
- K091940: Magpro, Models R30 with Magoption, X100, X100 with Magoption, Tonica Elektronik A/S (2010) Summary page 4.

## Indications for use
The MEP Monitor is an accessory for the MagPro stimulators (MagPro R30, MagPro R30 including MagOption, MagPro X100, and MagPro X100 including MagOption) and is intended to monitor evoked potentials.

Source page: https://510kreport.com/device/K162873
Methodology: https://510kreport.com/methodology