# K072382: Model I-2000 Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Infinite Biomedical Technologies
- Decided: Feb 15, 2008 after 175 days
- Product code: OLT (Non-Normalizing Quantitative Electroencephalograph Software)
- 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: 4 generations back to K963644 (1996). 11 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030489: BRM2 Brain Monitor, Brainz Instruments, Ltd. (2003) Summary page 1.
- K053386: Xltek EMU40 Eeg Headbox, Model PK1072, Excel Tech., Ltd. (2006) Summary page 1.

## Most influential descendants
- K082886: Zoom-100DC (2009), 11 descendants of its own
- K092477: NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701 (2010), 6 descendants of its own
- K142834: DiscoverEEG System, Model DE-401 (2015), 5 descendants of its own
- K120485: Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT P (2012), 5 descendants of its own
- K213299: Wireless EEG System (2022), 2 descendants of its own

## Indications for use
The I - 2000 Monitor is an electroencephalograph as per CFR §882.1400. It is used to measure and record the electrical activity of a patient’s brain, obtained by placing electrodes on the head. The I-2000 Monitor is intended to monitor the state of the brain by acquisition of electroencephalogram (EEG) signals, in research and clinical environments.

Source page: https://510kreport.com/device/K072382
Methodology: https://510kreport.com/methodology