# OLT: Non-Normalizing Quantitative Electroencephalograph Software

- Device class: 2; regulation: 21 CFR 882.1400; FDA's rule: 510(k) required
- FDA decisions: 57
- 510(k) review time 2021–2025: median 175 days (middle half 168–222)
- 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)
- 2009: 2
- 2013: 1
- 2014: 1
- 2015: 5
- 2019: 2
- 2020: 1
- 2022: 2
- 2024: 1
- 2025: 2
- 2026: 3

## Most-cited predicates
- K080546: Nihon Kohden Eeg-1200A Series Neurofax, Model Eeg-1200A (2008), cited by 5
- K000068: Compumedics E-Series Eeg System (2000), cited by 4
- K030489: BRM2 Brain Monitor (2003), cited by 3
- K141316: Cognision Eeg/EP System (2015), cited by 3
- K082886: Zoom-100DC (2009), cited by 3
- K072382: Model I-2000 Monitor (2008), cited by 2
- K033010: BRM2 Brain Monitor (2003), cited by 2
- K142064: Galileo NT (2015), cited by 2
- K923043: Spectral Eeg Monitor Model A1000 (1992), cited by 2
- K213299: Wireless EEG System (2022), cited by 2

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