# OMC: Reduced- Montage Standard Electroencephalograph

- Device class: 2; regulation: 21 CFR 882.1400; FDA's rule: 510(k) required
- FDA decisions: 29
- 510(k) review time 2021–2025: median 90 days (middle half 87–166)
- 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)
- 2015: 1
- 2017: 1
- 2019: 1
- 2020: 1
- 2021: 1
- 2022: 1
- 2023: 2
- 2024: 3
- 2025: 3
- 2026: 1

## Most-cited predicates
- K170363: Ceribell Pocket EEG Device (2017), cited by 7
- K183529: AE-120A EEG Head Set (2019), cited by 3
- K060523: Neuroport Neural Signal Processing System (2006), cited by 2
- K221563: Neurosteer EEG Recorder (2022), cited by 2
- K203827: REMI (2021), cited by 2
- K130013: X4 System (2013), cited by 2
- K120447: X4 (2012), cited by 1
- K192549: Byteflies Kit (2020), cited by 1
- K152040: X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29) (2015), cited by 1
- K013863: Crystal Monitor Model 16 (2002), cited by 1

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