# K030489: BRM2 Brain Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Brainz Instruments, Ltd.
- Decided: May 2, 2003 after 77 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: 3 generations back to K963644 (1996). 8 ancestors in all.
25 later devices descend from it; 3 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974496: A-2000 Eeg Monitor with Bis, Aspect Medical Systems, Inc. (1998) Summary page 1.
- K983229: Olympic Medical Lectromed Cerebral Function Monitor System, Olympic Medical Corp. (1999) Summary page 1.
- K982636: Patient Warmer- Model PW810, Fisher & Paykel Healthcare, Ltd. (1998) Summary page 1.

## Most influential descendants
- K033010: BRM2 Brain Monitor (2003), 23 descendants of its own
- K071449: BRM3 Brain Monitor (2007), 15 descendants of its own
- K080217: Component Neuromonitoring System (2008), 14 descendants of its own
- K072382: Model I-2000 Monitor (2008), 12 descendants of its own
- K082886: Zoom-100DC (2009), 11 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/K030489
Methodology: https://510kreport.com/methodology