# NVP: Holding Chambers, Direct Patient Interface

- Device class: 2; regulation: 21 CFR 868.5630; FDA's rule: 510(k) required
- FDA decisions: 16
- 510(k) review time 2021–2025: median 266 days (middle half 199–333)
- 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)
- 2008: 1
- 2011: 4
- 2012: 1
- 2013: 2
- 2014: 1
- 2016: 1
- 2017: 1
- 2019: 1
- 2022: 1
- 2025: 1

## Most-cited predicates
- K070674: Aerochamber Plus Anti-Static Valved Holding Chamber with Flow-VU Inspiratory Flow Indicator (2007), cited by 5
- K052332: Aerochamber Z-Stat Plus Valved Holding Chamber (2005), cited by 3
- K112010: Aerochamber Plus Flow-VU Anti-Static Valved Holding Chamber (VHC) (2012), cited by 1
- K181649: AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) (2019), cited by 1
- K160109: Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber (2017), cited by 1

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