# BYI: Percussor, Powered-Electric

- Device class: 2; regulation: 21 CFR 868.5665; FDA's rule: 510(k) required
- FDA decisions: 58
- 510(k) review time 2021–2025: median 157 days (middle half 124–224)
- Recalls: 2 (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)
- 2012: 1
- 2013: 3
- 2015: 1
- 2017: 1
- 2018: 1
- 2021: 2
- 2022: 1
- 2024: 3
- 2025: 1
- 2026: 1

## Most-cited predicates
- K024309: The Vest Airway Clearance System, Model 104 (2003), cited by 4
- K972859: Flutter D (1998), cited by 4
- K965192: Thairapy Vest System (1997), cited by 3
- K142482: The Vest Airway Clearance System (2015), cited by 3
- K884098: Thairapy (TM) Bronchial Drainage System, Model 101 (1988), cited by 3
- K946083: Flutter (R) (1995), cited by 3
- K053248: Smartvest Airway Clearance System, Model TL (2005), cited by 2
- K940986: Flutter (R) (1994), cited by 2
- K031876: Electro Flo Percussor, Model 5000 (2003), cited by 2
- K100749: Frequencer Model V2X (2010), cited by 2

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