# OLU: Normalizing Quantitative Electroencephalograph Software

- Device class: 2; regulation: 21 CFR 882.1400; FDA's rule: 510(k) required
- FDA decisions: 13
- 510(k) review time 2021–2025: median 220 days (middle half 199–371)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1998: 1
- 2004: 1
- 2005: 1
- 2012: 1
- 2014: 1
- 2018: 1
- 2020: 2
- 2023: 2
- 2024: 1
- 2026: 1

## Most-cited predicates
- K041263: Neuroguide Analysis System (2004), cited by 9
- K974748: Neurometric Analysis System (1998), cited by 4
- K171414: qEEG-Pro (2018), cited by 3
- K050192: BRC Software Product (2005), cited by 2
- K904294: QSI 9500 (1991), cited by 2
- K121119: Bna Analysis System (2014), cited by 1
- K112077: Hbidb - Human Brian Index Software (2012), cited by 1
- K202588: BNA Platform (2020), cited by 1

Source page: https://510kreport.com/product-code/OLU
Data by year (CSV): https://510kreport.com/product-code/OLU.csv