# OHP: Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea

- Device class: 2; regulation: 21 CFR 872.5570; FDA's rule: 510(k) required
- FDA decisions: 5
- Recalls: 1 (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
- 2009: 1
- 2010: 1
- 2018: 1
- 2020: 1

## Most-cited predicates
- K071560: Provent Nasal Dilator, Model BR2 (2008), cited by 3
- K102404: Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea Therapy (Provent 50) (2010), cited by 2
- K180619: Bongo (2018), cited by 1
- K090398: Provent Professional Sleep Apnea Therapy (2009), cited by 1

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