# PLC: Sleep Appliances With Patient Monitoring

- Device class: 2; regulation: 21 CFR 872.5570; FDA's rule: 510(k) required
- FDA decisions: 10
- 510(k) review time 2021–2025: median 338 days (middle half 338–338)
- 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)
- 2015: 1
- 2016: 2
- 2017: 2
- 2019: 1
- 2020: 1
- 2024: 1
- 2026: 2

## Most-cited predicates
- K150369: SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent G2 (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent Fusion (Classic or Flex Retention) with DentiTrac Micro-recorder (2015), cited by 5
- K161624: MicrO2 OSA Device with Micro-Recorder (2016), cited by 2
- K252765: ProSomnus RPMO2 OSA Device (RPMO2 OSA) (2026), cited by 1
- K172859: Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder (2017), cited by 1

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