# BWF: Spirometer, Therapeutic (Incentive)

- Device class: 2; regulation: 21 CFR 868.5690; FDA's rule: 510(k) required
- FDA decisions: 108
- 510(k) review time 2021–2025: median 284 days (middle half 160–420)
- 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)
- 2016: 3
- 2017: 3
- 2018: 1
- 2019: 3
- 2020: 1
- 2021: 1
- 2022: 1
- 2023: 2
- 2024: 1
- 2025: 1

## Most-cited predicates
- K002768: Acapella (2000), cited by 7
- K991561: Roadrunner, Pep Therapy Device (1999), cited by 4
- K962749: Therapep W/Mouthpiece, W/Pediatric Mask, W/Small Mask, W/Large Mask, Resistor/Port/Mouthpiece, Resistor/Port (1996), cited by 3
- K022906: Resqpod Circulatory Enhancer (2003), cited by 3
- K991300: Boeing, Positive Airway Pressure (Pap) Therapy Device (1999), cited by 3
- K033401: Modification to Resqpod Circulatory Enhancer (2003), cited by 2
- K133873: Triball Incentive Spirometer (2014), cited by 2
- K983308: RC Cornet, Model #44F50 (1999), cited by 2
- K954492: Mercury Medical Expiratory Resistance Exerciser, Resistex (1996), cited by 2
- K944900: Therapep (1995), cited by 2

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