# MRO: Apparatus, Nitric Oxide, Backup Delivery

- Device class: 2; regulation: 21 CFR 868.5165; FDA's rule: 510(k) required
- FDA decisions: 4
- 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)
- 2001: 2
- 2005: 1
- 2012: 1

## Most-cited predicates
- K052663: Ino Therapeutics Inoblender, Model 10004 (2005), cited by 2
- K003665: Fadassi Medical FM-1 NO Blender (2001), cited by 2
- K122689: Inoblender (2012), cited by 1
- K011874: Fadasis Medical FM-1 NO Blender (2001), cited by 1

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