BYI
- Product code
- BYI
- Device name
- Percussor, Powered-Electric
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.5665
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 5
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 58 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252849 | 2026-04-30 | Tactile Medical | AffloVest® Mobile Airway Clearance Therapy | |
| K250860 | 2025-10-02 | Exemplar Medical, LLC | BreatheBand® (Model 1000) | |
| K242063 | 2024-12-19 | Synchrony Medical , Ltd. | LibAirty Airway Clearance System | |
| K240959 | 2024-12-18 | Chongqing Moffy Innovation Technology … | Respiratory Muscle Trainer | — |
| K233441 | 2024-03-22 | Baxter Healthcare Corportation | The Vest APX System (PVAPX1) |
Official FDA classification page: BYI
Classification and pathway per current FDA publications. Data from openFDA (CC0).