# OLZ: Automatic Event Detection Software For Polysomnograph With Electroencephalograph

- Device class: 2; regulation: 21 CFR 882.1400; FDA's rule: 510(k) required
- FDA decisions: 38
- 510(k) review time 2021–2025: median 155 days (middle half 133–248)
- 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)
- 2017: 2
- 2018: 1
- 2019: 2
- 2020: 1
- 2021: 1
- 2022: 1
- 2023: 2
- 2024: 2
- 2025: 4
- 2026: 3

## Most-cited predicates
- K040595: ALICE 5 (2004), cited by 7
- K915856: Sensormedics 4000 Series Sleep System (1992), cited by 5
- K162627: EnsoSleep (2017), cited by 5
- K090277: Natus Sleepworks, Model 104017 (2011), cited by 4
- K153412: Sleep Profiler (2016), cited by 4
- K192469: Nox Sleep System (2019), cited by 3
- K062943: Polysmith Sleep System, Model NTI5498 (2007), cited by 3
- K173366: NicoletOne (2018), cited by 2
- K120450: Sleep Profiler (2012), cited by 2
- K142988: Sleepware G3 (2015), cited by 2

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