AffloVest® Mobile Airway Clearance Therapy— 510(k) K252849
Substantially EquivalentTactile Medical
FDA 510(k) clearance K252849 for AffloVest® Mobile Airway Clearance Therapy, Substantially Equivalent on 2026-04-30. Applicant: Tactile Medical. Device class: 2.
Summary
Tactile Medical's AffloVest Mobile Airway Clearance Therapy is filed under product code BYI (Percussor, Powered-Electric).
Class II, 21 CFR 868.5665. Anesthesiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Tactile Medical filed from Minneapolis, Minnesota. The record shows 234 calendar days from receipt to decision (September 8, 2025 to April 30, 2026).
Clearance details
- Applicant
- Tactile Medical
- Product code
- Product code BYI
- Device class
- Class 2
- Regulation
- 21 CFR 868.5665
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
Recent devices under product code BYI
view allMore clearances from Tactile Medical
view allAdverse events under product code BYI
product code BYI- Death
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.