# LEL: Device, Sleep Assessment

- Device class: 2; regulation: 21 CFR 882.5050; FDA's rule: 510(k) required
- FDA decisions: 19
- 510(k) review time 2021–2025: median 119 days (middle half 77–152)
- 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)
- 1998: 1
- 2001: 1
- 2004: 2
- 2011: 1
- 2014: 1
- 2016: 1
- 2018: 1
- 2023: 1
- 2024: 2
- 2025: 3

## Most-cited predicates
- K132764: Motion Watch and Pro-Diary (2014), cited by 4
- K111514: SBV2, Multicharger Model MC10V2 (2011), cited by 2
- K181077: ActiGraph CentrePoint Insight Watch (2018), cited by 2
- K231532: ActiGraph LEAP activity monitor (ActiGraph LEAP) (2023), cited by 1
- K981969: Ultima Body Position Sensor (1998), cited by 1
- K252981: EmbraceMini (2025), cited by 1

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