AffloVest® Mobile Airway Clearance Therapy

FDA 510(k) K252849 · Tactile Medical

Substantially Equivalent

510(k) numberK252849

Submission

Device name
AffloVest® Mobile Airway Clearance Therapy
Applicant
Tactile Medical
Minneapolis, MN, US
Received
September 8, 2025
Decision date
April 30, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BYI – Percussor, Powered-Electric
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5665
Specialty
Anesthesiology

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K173603Monarch Airway Clearance SystemBYI · Traditional Hill-Rom Holdings, Inc.10/24/2018SE
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Questions and answers

When was AffloVest® Mobile Airway Clearance Therapy cleared by the FDA?

AffloVest® Mobile Airway Clearance Therapy (K252849) received a 510(k) decision of Substantially Equivalent on April 30, 2026, 234 days after the submission was received.

What is the product code of K252849?

The FDA product code is BYI – Percussor, Powered-Electric, a Class II (moderate risk) device regulated under 21 CFR 868.5665.