Cleared Traditional

K252849 - AffloVest Mobile Airway Clearance Therapy

K252849 is an FDA 510(k) clearance for AffloVest Mobile Airway Clearance Therapy, manufactured by Tactile Medical. The device is a Class 2 Anesthesiology device with product code BYI cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K252849 · Tactile Medical · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Apr 2026
Decision
234d
Days
Class 2
Risk

K252849 is an FDA 510(k) clearance for the AffloVest® Mobile Airway Clearance Therapy. Classified as Percussor, Powered-electric (product code BYI), Class II - Special Controls.

Submitted by Tactile Medical (Minneapolis, US). The FDA issued a Cleared decision on April 30, 2026 after a review of 234 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5665 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Tactile Medical devices

FDA 510(k) Submission Details - K252849

510(k) Number K252849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2025
Decision Date April 30, 2026
Days to Decision 234 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 140d · This submission: 234d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BYI Device Classification - Class 2, Special Controls

Product Code BYI Percussor, Powered-electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5665
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Consultant

DuVal & Associates, P.A.
Jessica Buell

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - BYI Percussor, Powered-electric

All 17
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