# K253767: UB ERP System

- Pathway: 510(k) (Traditional)
- Applicant: Universal Brain
- Decided: Jun 30, 2026 after 217 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: 12 generations back to K873535 (1987). 47 ancestors in all.
No later device cites it as a predicate yet.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192753: NeuralScan System, Medeia, Inc. (2020) Summary page 5.
- K221963: Cumulus Functional Neurophysiology Platform, Cumulus Neuroscience Limited (2023) Summary page 5.

## Indications for use
The UB ERP System is intended for the acquisition, display, analysis, storage and reporting of electrical activity of a patient’s brain, including electroencephalography (EEG) signals and event-related potentials (ERPs), obtained by placing two or more electrodes on the head of adults and adolescent patients to aid in diagnosis. The EEG signals are time-stamped. It is used with an UB EEG Cap loaded with appropriate software and connected to a Windows PC using a USB cable. The UB ERP System is to be used in a health care facility or a clinic under the direction of a healthcare professional. The UB ERP System does not draw any diagnostic conclusion. A clinical expert must interpret recorded EEG signals. The results of such interpretation should be considered only in conjunction with other clinical findings.

Source page: https://510kreport.com/device/K253767
Methodology: https://510kreport.com/methodology