# K033010: BRM2 Brain Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Brainz Instruments, Ltd.
- Decided: Oct 10, 2003 after 14 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). 13 ancestors in all.
23 later devices descend from it; 2 cite it directly.
0 of 37 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.
- K960732: Hydrospot Eeg Electrode Model 1501, Hydrospot Leadwire Model 1500, Physiometrix, Inc. (1996) Summary page 1.
- K911529: Bunny Electrode/Stealth Electrode Pre Wired Eeg, Lead-Lok, Inc. (1992) Summary page 1.
- K000206: Pals Neonatal Pediatric Ecg Electrode, Models PN100, PN200, Axelgaard Mfg. Co., Ltd. (2000) Summary page 1.

## Most influential descendants
- K071449: BRM3 Brain Monitor (2007), 15 descendants of its own
- K080217: Component Neuromonitoring System (2008), 14 descendants of its own
- K082886: Zoom-100DC (2009), 11 descendants of its own
- K081551: Twin Neurotrac-Iii (2008), 8 descendants of its own
- K092573: Nihon Kohden QP-160AK Eeg Trend Program (2010), 7 descendants of its own

## Indications for use
The Brainz Instruments Ltd BRM2 Brain Monitor is an Electroencephalograph as per 21 CFR §882.1400 (a device used to measure and record the electrical activity of the patient’s brain obtained by placing two or more electrodes on the head). The BRM2 Brain Monitor is intended to monitor the state of the brain by acquisition of electroencephalogram (EEG) signals, in the intensive care unit, operating room, and for clinical research.

Source page: https://510kreport.com/device/K033010
Methodology: https://510kreport.com/methodology