# OMB: Automatic Event Detection Software For Full-Montage Electroencephalograph

- Device class: 2; regulation: 21 CFR 882.1400; FDA's rule: 510(k) required
- FDA decisions: 42
- 510(k) review time 2021–2025: median 189 days (middle half 162–240)
- Recalls: 1 (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)
- 2017: 1
- 2018: 3
- 2019: 1
- 2020: 1
- 2021: 1
- 2022: 1
- 2023: 2
- 2024: 5
- 2025: 5
- 2026: 1

## Most-cited predicates
- K132306: Persyst 12 Eeg Review and Analysis Software (2013), cited by 5
- K191301: Ceribell Pocket EEG Device (2019), cited by 5
- K151929: Persyst 13 (P13) Eeg Review and Analysis Software (2015), cited by 5
- K182181: Persyst 14 EEG Review and Analysis Software (2018), cited by 4
- K011397: Persyst Reveal (2001), cited by 4
- K090019: Natus Neuroworks, Model 104196 (2010), cited by 3
- K171720: encevis (2018), cited by 3
- K092039: Identevent, Version 1.0G (2009), cited by 2
- K240993: encevis (2.1) (2024), cited by 2
- K951594: Bio-Logic Automatic Event Analysis (1995), cited by 2

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