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

Name: FDA 510(k) clearance K252849
Creator: U.S. Food and Drug Administration
Published: 2026-04-30

Substantially Equivalent

Tactile Medical

FDA 510(k) clearance K252849 for AffloVest® Mobile Airway Clearance Therapy, Substantially Equivalent on 2026-04-30. Applicant: Tactile Medical. Device class: 2.

Clearance details

Applicant: Tactile Medical
Product code: Code BYI
Device class: Class 2
Regulation: 21 CFR 868.5665
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 ↗

Recent devices under product code BYI

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K250860 — BreatheBand® (Model 1000)2025-10-02
K242063 — LibAirty Airway Clearance System2024-12-19
K240959 — Respiratory Muscle Trainer2024-12-18
K233441 — The Vest APX System (PVAPX1)2024-03-22
K222496 — Electromed SmartVest Airway Clearance System2022-11-18

More clearances from Tactile Medical

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K253555 — Flexitouch® Plus Advanced Pneumatic Compression System2026-07-31
K234155 — Nimbl (model PD08-N1)2024-06-21

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.