# LRK: Device, Anti-Snoring

- Device class: 2; regulation: 21 CFR 872.5570; FDA's rule: 510(k) required
- FDA decisions: 217
- 510(k) review time 2021–2025: median 137 days (middle half 90–233)
- Recalls: 4 (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: 7
- 2018: 10
- 2019: 13
- 2020: 5
- 2021: 10
- 2022: 11
- 2023: 5
- 2024: 6
- 2025: 14
- 2026: 10

## Most-cited predicates
- K050592: Somnomed Mas Rxa (2005), cited by 17
- K962516: Tap Anti-Snoring Device (1996), cited by 13
- K170825: SnoreRx (2017), cited by 11
- K972061: TOA (1997), cited by 10
- K971794: Elastic Mandibular Advancement (Ema) Appliance (1997), cited by 10
- K061688: Anti-Snoring / Sleep Apnea Device (2006), cited by 9
- K073004: Somnomed  Bflex (2008), cited by 8
- K083209: Acrylic Herbst Splint Appliance (2009), cited by 7
- K882303: H&M Anti-Snoring Device (1989), cited by 7
- K103076: Dynaflex (2011), cited by 6

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