Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5665](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5665) → BYI — Percussor, Powered-Electric # BYI · Percussor, Powered-Electric _Anesthesiology · 21 CFR 868.5665 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYI ## Overview - **Product Code:** BYI - **Device Name:** Percussor, Powered-Electric - **Regulation:** [21 CFR 868.5665](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5665) - **Device Class:** 2 - **Review Panel:** [Anesthesiology](/submissions/AN) - **3rd-party reviewable:** yes ## Identification A powered percussor is a device that is intended to transmit vibration through a patient's chest wall to aid in freeing mucus deposits in the lung in order to improve bronchial drainage and that may be powered by electricity or compressed gas. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 57) Showing 20 most recent of 57 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K250860](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYI/K250860.md) | BreatheBand® (Model 1000) | Exemplar Medical, LLC | Oct 2, 2025 | SESE | | [K242063](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYI/K242063.md) | LibAirty Airway Clearance System | Synchrony Medical , Ltd. | Dec 19, 2024 | SESE | | [K240959](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYI/K240959.md) | Respiratory Muscle Trainer | Chongqing Moffy Innovation Technology Co., Ltd. | Dec 18, 2024 | SESE | | [K233441](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYI/K233441.md) | The Vest APX System (PVAPX1) | Baxter Healthcare Corportation | Mar 22, 2024 | SESE | | [K222496](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYI/K222496.md) | Electromed SmartVest Airway Clearance System | Electromed, Inc. | Nov 18, 2022 | SESE | | [K201490](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYI/K201490.md) | Electro Flo 6 Airway Clearance System | Med Systems, Inc. | Feb 12, 2021 | SESE | | [K203209](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYI/K203209.md) | AirPhysio Positive Expiratory Pressure (PEP) Device | Airphysio Pty, Ltd. | Jan 15, 2021 | SESE | | [K173603](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYI/K173603.md) | Monarch Airway Clearance System | Hill-Rom Holdings, Inc. | Oct 24, 2018 | SESE | | [K163378](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYI/K163378.md) | Monarch Airway Clearance System | Hill-Rom Services Pte, Ltd. | Mar 17, 2017 | SESE | | [K142482](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYI/K142482.md) | The Vest Airway Clearance System | Hill-Rom Services Private Limited | May 7, 2015 | SESE | | [K132794](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYI/K132794.md) | SMARTVEST AIRWAY CLEARANCE SYSTEM | Electromed, Inc. | Dec 19, 2013 | SESE | | [K121587](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYI/K121587.md) | BREATH SHAKE | Cheen Houng Ent. Co. , Ltd. | Nov 22, 2013 | SESE | | [K122480](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYI/K122480.md) | INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST | International Biophysics Corporation | Mar 27, 2013 | SESE | | [K121170](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYI/K121170.md) | RESIN 11 | Respinnovation Sas | Jul 13, 2012 | SESE | | [K103176](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYI/K103176.md) | FREQUENCER | Dymedso, Inc. | Jan 26, 2011 | SESE | | [K100749](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYI/K100749.md) | FREQUENCER MODEL V2X | Dymedso, Inc. | Aug 31, 2010 | SESE | | [K063645](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYI/K063645.md) | FREQUENCER, MODEL 1001 | Dymedso, Inc. | Mar 15, 2007 | SESE | | [K060439](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYI/K060439.md) | LUNG FLUTE | Medical Acoustics, LLC | Jun 22, 2006 | SESE | | [K053248](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYI/K053248.md) | SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL | Electromed, Inc. | Dec 1, 2005 | SESE | | [K051383](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYI/K051383.md) | THE INCOURAGE SYSTEM | Respiratory Technologies, Incorporated | Jun 17, 2005 | SESE | ## Top Applicants - Electromed, Inc. — 5 clearances - American Biosystems, Inc. — 4 clearances - Dymedso, Inc. — 3 clearances - Strom Corp. — 3 clearances - Advanced Respiratory — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYI](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYI) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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