UB ERP System— 510(k) K253767

Name: FDA 510(k) clearance K253767
Creator: U.S. Food and Drug Administration
Published: 2026-06-30

Substantially Equivalent

Universal Brain

FDA 510(k) clearance K253767 for UB ERP System, Substantially Equivalent on 2026-06-30. Applicant: Universal Brain. Device class: 2.

Summary

Universal Brain's UB ERP System is filed under OLT, non-normalizing quantitative electroencephalograph software. The record doesn't expand the name or describe the system beyond the code name.

Class II, 21 CFR 882.1400. Neurology is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Universal Brain filed from Palo Alto, California. Review took 217 calendar days (November 25, 2025 to June 30, 2026).

Clearance details

Applicant: Universal Brain
Product code: Product code OLT
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2025-11-25
Decision date: 2026-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, US

Download summary PDF View on FDA.gov ↗

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K251366 — EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)2025-10-09
K240593 — VEEGix EEG System2024-08-23

Adverse events under product code OLT

product code OLT

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.