# OMA: Amplitude-Integrated Electroencephalograph

- Device class: 2; regulation: 21 CFR 882.1400; FDA's rule: 510(k) required
- FDA decisions: 16
- 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)
- 2003: 1
- 2007: 1
- 2008: 2
- 2010: 2
- 2012: 1
- 2013: 2
- 2015: 1
- 2016: 2
- 2017: 1
- 2020: 1

## Most-cited predicates
- K080217: Component Neuromonitoring System (2008), cited by 5
- K983229: Olympic Medical Lectromed Cerebral Function Monitor System (1999), cited by 4
- K120485: Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT P (2012), cited by 3
- K031149: Olympic CFM 6000 (2003), cited by 3
- K071449: BRM3 Brain Monitor (2007), cited by 2
- K093949: Olympic Brainz Monitor Model OBM70001 (2010), cited by 2
- K092573: Nihon Kohden QP-160AK Eeg Trend Program (2010), cited by 2
- K161027: Cadwell AmpliScan (2016), cited by 1
- K791580: Cerebral Function Monitor 870 (1979), cited by 1
- K081551: Twin Neurotrac-Iii (2008), cited by 1

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