Clearance Summary
AffloVest® Mobile Airway Clearance Therapy received FDA 510(k) clearance under submission number K252849, sponsored by Tactile Medical. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2026-04-30.
- Submission: K252849
- Applicant / Sponsor: Tactile Medical
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5665
- Decision date: 2026-04-30
Classification & Regulation
This clearance is catalogued under FDA product code BYI and 21 CFR 868.5665, within the Anesthesiology review panel as a Class II device.