# MNR: Ventilatory Effort Recorder

- Device class: 2; regulation: 21 CFR 868.2375; FDA's rule: 510(k) required
- FDA decisions: 165
- 510(k) review time 2021–2025: median 181 days (middle half 125–269)
- Recalls: 6 (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: 4
- 2018: 3
- 2019: 8
- 2020: 5
- 2021: 3
- 2022: 7
- 2023: 6
- 2024: 6
- 2025: 10
- 2026: 5

## Most-cited predicates
- K060708: Somnoscreen (2007), cited by 6
- K090958: Inomax DS (Delivery System) (2009), cited by 6
- K024322: Embla N7000 (2003), cited by 5
- K112514: Apnea Risk Evaluation System (Ares) (2012), cited by 5
- K955841: Sleep System for Clinics & Research (1997), cited by 5
- K082113: Nox T3, Noxturnal (PC Application) (2008), cited by 4
- K041904: Compass F10 System (2004), cited by 4
- K090484: Alice PDX (2009), cited by 4
- K042745: Lifescreen Apnea (2005), cited by 4
- K021176: Compumedics Somte System (2003), cited by 4

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