# K213273: Brain Anesthesia Response Monitor (Bar Monitor)

- Pathway: 510(k) (Traditional)
- Applicant: Cortical Dynamics, Ltd.
- Decided: Sep 1, 2023 after 701 days
- Product code: OLW (Index-Generating 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: 9 generations back to K963644 (1996). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072286: Bis Eeg Vista Monitor System and Bisx, Aspect Medical Systems, Inc. (2007) Summary page 4.

## Indications for use
The BAR Monitor is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system displays a patient's EEG and Composite Cortical State (CCS), a proprietary computed EEG index related to the effect of certain anesthetic or hypnotic agents. Anesthetic agents include inhalation agents and propofol in combination with opioids. The BAR Monitor is intended to assist medical professionals monitor adult patients (22 to 65 years of age) in the operating room (OR) and clinical research laboratory.

Source page: https://510kreport.com/device/K213273
Methodology: https://510kreport.com/methodology