BYI · Class II · 21 CFR 868.5665

FDA Product Code BYI: Percussor, Powered-electric

Leading manufacturers include Electromed, Inc., Dymedso, Inc. and American Biosystems, Inc..

58
Total
58
Cleared
120d
Avg days
1977
Since
Growing category - 4 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 210d recently vs 113d historically

FDA 510(k) Cleared Percussor, Powered-electric Devices (Product Code BYI)

58 devices
1–24 of 58
Cleared Apr 30, 2026
AffloVest® Mobile Airway Clearance Therapy
K252849
Tactile Medical
Anesthesiology · 234d
Cleared Oct 02, 2025
BreatheBand® (Model 1000)
K250860
Exemplar Medical, LLC
Anesthesiology · 195d
Cleared Dec 19, 2024
LibAirty Airway Clearance System
K242063
Synchrony Medical , Ltd.
Anesthesiology · 157d
Cleared Dec 18, 2024
Respiratory Muscle Trainer
K240959
Chongqing Moffy Innovation Technology Co., Ltd.
Anesthesiology · 254d
Cleared Mar 22, 2024
The Vest APX System (PVAPX1)
K233441
Baxter Healthcare Corportation
Anesthesiology · 156d
Cleared Nov 18, 2022
Electromed SmartVest Airway Clearance System
K222496
Electromed, Inc.
Anesthesiology · 92d
Cleared Feb 12, 2021
Electro Flo 6 Airway Clearance System
K201490
Med Systems, Inc.
Anesthesiology · 253d
Cleared Jan 15, 2021
AirPhysio Positive Expiratory Pressure (PEP) Device
K203209
Airphysio Pty, Ltd.
Anesthesiology · 77d
Cleared Oct 24, 2018
Monarch Airway Clearance System
K173603
Hill-Rom Holdings, Inc.
Anesthesiology · 337d
Cleared Mar 17, 2017
Monarch Airway Clearance System
K163378
Hill-Rom Services Pte, Ltd.
Anesthesiology · 106d
Cleared May 07, 2015
The Vest Airway Clearance System
K142482
Hill-Rom Services Private Limited
Anesthesiology · 245d
Cleared Dec 19, 2013
SMARTVEST AIRWAY CLEARANCE SYSTEM
K132794
Electromed, Inc.
Anesthesiology · 104d
Cleared Nov 22, 2013
BREATH SHAKE
K121587
Cheen Houng Ent. Co. , Ltd.
Anesthesiology · 540d
Cleared Mar 27, 2013
INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST
K122480
International Biophysics Corporation
Anesthesiology · 225d
Cleared Jul 13, 2012
RESIN 11
K121170
Respinnovation Sas
Anesthesiology · 87d
Cleared Jan 26, 2011
FREQUENCER
K103176
Dymedso, Inc.
Anesthesiology · 90d
Cleared Aug 31, 2010
FREQUENCER MODEL V2X
K100749
Dymedso, Inc.
Anesthesiology · 168d
Cleared Mar 15, 2007
FREQUENCER, MODEL 1001
K063645
Dymedso, Inc.
Anesthesiology · 98d
Cleared Jun 22, 2006
LUNG FLUTE
K060439
Medical Acoustics, LLC
Anesthesiology · 121d
Cleared Dec 01, 2005
SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL
K053248
Electromed, Inc.
Anesthesiology · 10d
Cleared Jun 17, 2005
THE INCOURAGE SYSTEM
K051383
Respiratory Technologies, Incorporated
Anesthesiology · 21d
Cleared Oct 09, 2001
ABI VEST AIRWAY CLEARANCE SYSTEM
K012928
Advanced Respiratory
Anesthesiology · 39d
Cleared Jan 21, 2000
ABI VEST AIRWAY CLEARANCE SYSTEM
K993629
American Biosystems, Inc.
Anesthesiology · 86d
Cleared Jun 01, 1999
MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000
K982889
Electromed, Inc.
Anesthesiology · 288d

About Product Code BYI - Regulatory Context

510(k) Submission Activity

58 total 510(k) submissions under product code BYI since 1977, with 58 receiving FDA clearance (average review time: 120 days).

Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - BYI Product Code

Recent submissions under BYI have taken an average of 210 days to reach a decision - up from 113 days historically. Manufacturers should account for longer review timelines in current project planning.

BYI devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →