# OLV: Standard Polysomnograph With Electroencephalograph

- Device class: 2; regulation: 21 CFR 882.1400; FDA's rule: 510(k) required
- FDA decisions: 65
- 510(k) review time 2021–2025: median 250 days (middle half 220–274)
- 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)
- 2011: 2
- 2013: 1
- 2015: 1
- 2017: 3
- 2018: 3
- 2020: 2
- 2022: 1
- 2024: 2
- 2025: 1
- 2026: 2

## Most-cited predicates
- K971813: EMBLA (1998), cited by 7
- K003175: Compumedics Siesta System (2000), cited by 6
- K021185: Nervus Monitor (2002), cited by 6
- K934599: Sandman (1994), cited by 4
- K021807: Grass-Telefactor AS40 Amplifier System (2002), cited by 4
- K971867: Alice 4R System (1997), cited by 4
- K101830: Zmachine, Model DT-100 (2011), cited by 4
- K022121: PSG Input Box, Model JE-912AK (2002), cited by 3
- K142774: Polysmith Sleep System (2015), cited by 3
- K991900: Xltek Polysomnography Headbox, Model # PSG-40 (1999), cited by 3

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