# K110410: MS-120BK Electric Stimulator (Extension Unit)

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden Corp.
- Decided: Aug 4, 2011 after 171 days
- Product code: GYC (Electrode, Cortical)
- Device class: 2
- Regulation: 21 CFR 882.1310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K842956 (1984). 17 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072964: Nicolet Cortical Stimulator, Cardinal Health, Inc. (2008) Summary page 1.
- K924226: Ojemann Cortical Stimulator, Radionics, Inc. (1993) Summary page 1.
- K020400: Digitimer D185 Multipulse Cortical Stimulator, Meps, LLC (2002) Summary page 1.
- K050798: Eclipse Neurological Workstation, Axon Systems, Inc. (2005) Summary page 1.
- K071969: Sen-4100 Electric Stimulator, Nihon Kohden America, Inc. (2008) Summary page 1.

## Most influential descendants
- K182542: The EPAD 2 System (2019), 9 descendants of its own
- K213849: SafeOp 2: Neural Informatix System (2022), 4 descendants of its own
- K234092: SafeOp 3: Neural Informatix Systeem (2024), 3 descendants of its own
- K182617: ATEC IOM Accessory Instruments (2019), 3 descendants of its own
- K191723: ATEC IOM Accessory Instruments (2019), 2 descendants of its own

## Indications for use
When the Low output is selected the MS-120BK is used as a nerve stimulator for surgical procedures and brain mapping during treatment of patients with seizure disorders. When High output is selected the MS-12OBK is 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. The system is intended for use by qualified medical personnel within a hospital or clinical environment. The stimulator is available for use on any patients as determined by the qualified medical personnel.

Source page: https://510kreport.com/device/K110410
Methodology: https://510kreport.com/methodology