# CAF: Nebulizer (Direct Patient Interface)

- Device class: 2; regulation: 21 CFR 868.5630; FDA's rule: 510(k) required
- FDA decisions: 509
- 510(k) review time 2021–2025: median 236 days (middle half 206–293)
- Recalls: 28 (13 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: 8
- 2018: 9
- 2019: 3
- 2020: 6
- 2021: 8
- 2022: 4
- 2023: 8
- 2024: 4
- 2025: 7
- 2026: 2

## Most-cited predicates
- K062263: Omron Micro-Air Vibrating Mesh Nebulizer, Model NE-U22 (2007), cited by 12
- K963924: LC Star Reusable Nebulizer 22F50 and LC Star Disposable Nebulizer 22F70 (1996), cited by 11
- K930525: Micro Mist (TM) Nebulizer (1993), cited by 6
- K935693: Autoneb Breath Actuated Controller and Accessory Kit (1994), cited by 5
- K133360: Aeroneb Solo; Aeroneb Solo Adapter (2014), cited by 4
- K914836: Omron Compressor Nebulizer- Model NE-C09 (1992), cited by 4
- K935955: DOSER (1994), cited by 4
- K926055: The Miller Nebulizer System (1993), cited by 4
- K142516: Propeller System (2015), cited by 4
- K023602: Small Volume Nebulizer (2003), cited by 4

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