# K950208: Nihon Kohden Neuropack Sigma Meb-5500A Evoked Response & Emg Measuring System

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden America, Inc.
- Decided: May 10, 1995 after 112 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
No predicates in its family tree.
14 later devices descend from it; 1 cites it directly.
0 of 15 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
- K991899: Nihon Kohden Meb-2200A Neuropack Evoked Potential & Emg Measuring System with Accessories (1999), 13 descendants of its own
- K051178: Mee-1000A Neuromaster (2005), 10 descendants of its own
- K142624: Neuromaster G1 MEE200 (2015), 8 descendants of its own
- K162199: Cascade IOMAX Intraoperative Monitor (2017), 7 descendants of its own
- K212166: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (2022), 5 descendants of its own

Source page: https://510kreport.com/device/K950208
Methodology: https://510kreport.com/methodology