# K131944: IEEG

- Pathway: 510(k) (Traditional)
- Applicant: Jordan Neuroscience, Inc.
- Decided: Apr 10, 2014 after 287 days
- Product code: OMC (Reduced- Montage Standard Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K963644 (1996). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082886: Zoom-100DC, Brainscope Company, Inc. (2009) Summary page 1.

## Indications for use
The iEEG device is intended to acquire and store electrical activity of the brain and patient data for review by a medical professional using a digital EEG system to monitor the state of the brain. The device is intended for use in a healthcare facility, clinical research environment, or in the home under the supervision of a qualified healthcare professional. The device is intended for use on all patient populations including pediatric.

Source page: https://510kreport.com/device/K131944
Methodology: https://510kreport.com/methodology