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FDA 510(k)

AffloVest® Mobile Airway Clearance Therapy

K-Number: K252849 · 2026-04-30

ApplicantTactile Medical
Decision Date2026-04-30
Product CodeBYI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AffloVest® Mobile Airway Clearance Therapy is the device name listed in this FDA 510(k) record. The listed applicant is Tactile Medical. It received FDA 510(k) clearance on 2026-04-30 under 510(k) number K252849. The device is classified under product code BYI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AffloVest® Mobile Airway Clearance Therapy?

AffloVest® Mobile Airway Clearance Therapy is a medical device that received FDA 510(k) clearance on 2026-04-30. The listed applicant is Tactile Medical. The 510(k) number is K252849.

When did AffloVest® Mobile Airway Clearance Therapy receive FDA 510(k) clearance?

AffloVest® Mobile Airway Clearance Therapy received FDA 510(k) clearance on 2026-04-30, under 510(k) number K252849.

Who is the listed applicant for AffloVest® Mobile Airway Clearance Therapy?

The FDA 510(k) record lists Tactile Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AffloVest® Mobile Airway Clearance Therapy?

The FDA product code for AffloVest® Mobile Airway Clearance Therapy is BYI.

Related Clinical Trials

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Other records listing Tactile Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253555Flexitouch® Plus Advanced Pneumatic Compression SystemK234155Nimbl (model PD08-N1)

Related Devices (Code: BYI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250860BreatheBand® (Model 1000)Exemplar Medical, LLCK242063LibAirty Airway Clearance SystemSynchrony Medical , Ltd.K240959Respiratory Muscle TrainerChongqing Moffy Innovation Technology Co., Ltd.K233441The Vest APX System (PVAPX1)Baxter Healthcare CorportationK222496Electromed SmartVest Airway Clearance SystemElectromed, Inc.K201490Electro Flo 6 Airway Clearance SystemMed Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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