# OLW: Index-Generating Electroencephalograph Software

- Device class: 2; regulation: 21 CFR 882.1400; FDA's rule: 510(k) required
- FDA decisions: 40
- 510(k) review time 2021–2025: median 424 days (middle half 345–549)
- 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)
- 2006: 2
- 2007: 3
- 2008: 2
- 2015: 1
- 2018: 1
- 2021: 1
- 2022: 1
- 2023: 1
- 2024: 1
- 2026: 2

## Most-cited predicates
- K040183: BISX (2004), cited by 10
- K974496: A-2000 Eeg Monitor with Bis (1998), cited by 6
- K963644: A-1000 Eeg Monitor and a-1050 Eeg Monitor (1996), cited by 5
- K072286: Bis Eeg Vista Monitor System and Bisx (2007), cited by 5
- K030267: Eeg Monitor with Bis, Model a-2000 (2004), cited by 4
- K011534: Eeg Mis Monitor Model # a-2000; Bis Engine (2001), cited by 3
- K052362: Bis Eeg Monitor, Model a-3000 (2005), cited by 2
- K172890: SedLine Sedation Monitor (2018), cited by 2
- K013389: Datex-Ohmeda S/5 Bis Module, M-Bis and Accessories (2002), cited by 2
- K023459: Datex-Ohmeda S/5 Entropy Module, M-Entropy and Accessories (2003), cited by 2

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