# MRN: Apparatus, Nitric Oxide Delivery

- Device class: 2; regulation: 21 CFR 868.5165; FDA's rule: 510(k) required
- FDA decisions: 33
- 510(k) review time 2021–2025: median 161 days (middle half 106–436)
- Recalls: 9 (2 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
- 2012: 3
- 2013: 2
- 2015: 1
- 2018: 1
- 2020: 3
- 2022: 1
- 2023: 4
- 2024: 2
- 2025: 2

## Most-cited predicates
- K061901: Ino Therapeutics Inomax DS (Delivery System), Model 10003 (2006), cited by 14
- K070867: Inomax DS (Delivery System), Model 10003 (2007), cited by 10
- K071516: Inomax DS (2007), cited by 9
- K092545: Inomax DS (Delivery System), Model 10003 (2010), cited by 7
- K093922: Inomax DS (2010), cited by 6
- K080484: Inomax DS (Delivery System), Model 10003 (2008), cited by 6
- K081691: Inomax DS (Delivery System) (2008), cited by 6
- K110635: Inomax DS (IR) (Delivery System) (2011), cited by 4
- K110344: Inomax Dsir (Delivery System) (2011), cited by 4
- K113272: Inomax DS (Delivery Systems (2012), cited by 3

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