AffloVest® Mobile Airway Clearance Therapy— 510(k) K252849

Substantially Equivalent

Tactile Medical

FDA 510(k) clearance K252849 for AffloVest® Mobile Airway Clearance Therapy, Substantially Equivalent on 2026-04-30. Applicant: Tactile Medical.

Clearance details

Applicant: Tactile Medical
Product code: Code BYI
Advisory panel: Anesthesiology
Date received: 2025-09-08
Decision date: 2026-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BYI

product code BYI

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.