Product Code: BYI FDA class 2 21 CFR 868.5665

Percussor, Powered-Electric

Anesthesiology

The Percussor, Powered-Electric is an electrically powered device that delivers rhythmic mechanical percussion to the chest wall to mobilize and loosen pulmonary secretions, facilitating their clearance in patients with respiratory conditions such as cystic fibrosis or chronic obstructive pulmonary disease. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BYI, regulated under 21 CFR 868.5665 in the Anesthesiology specialty. This device is eligible for third-party 510(k) review.

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FEI Numbers

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Basic Information

Product Code: BYI
Device Class: FDA class 2
Regulation Number: 868.5665
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 58 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252849	AffloVest® Mobile Airway Clearance Therapy	Apr 30, 2026	Substantially Equivalent	Tactile Medical
K250860	BreatheBand® (Model 1000)	Oct 02, 2025	Substantially Equivalent	Exemplar Medical, LLC
K242063	LibAirty Airway Clearance System	Dec 19, 2024	Substantially Equivalent	Synchrony Medical , Ltd.
K240959	Respiratory Muscle Trainer	Dec 18, 2024	Substantially Equivalent	Chongqing Moffy Innovation Technology Co., Ltd.
K233441	The Vest APX System (PVAPX1)	Mar 22, 2024	Substantially Equivalent	Baxter Healthcare Corportation
K222496	Electromed SmartVest Airway Clearance System	Nov 18, 2022	Substantially Equivalent	Electromed, Inc.
K201490	Electro Flo 6 Airway Clearance System	Feb 12, 2021	Substantially Equivalent	Med Systems, Inc.
K203209	AirPhysio Positive Expiratory Pressure (PEP) Device	Jan 15, 2021	Substantially Equivalent	Airphysio Pty, Ltd.
K173603	Monarch Airway Clearance System	Oct 24, 2018	Substantially Equivalent	Hill-Rom Holdings, Inc.
K163378	Monarch Airway Clearance System	Mar 17, 2017	Substantially Equivalent	Hill-Rom Services Pte, Ltd.
K142482	The Vest Airway Clearance System	May 07, 2015	Substantially Equivalent	Hill-Rom Services Private Limited
K132794	SMARTVEST AIRWAY CLEARANCE SYSTEM	Dec 19, 2013	Substantially Equivalent	Electromed, Inc.
K121587	BREATH SHAKE	Nov 22, 2013	Substantially Equivalent	Cheen Houng Ent. Co. , Ltd.
K122480	INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST	Mar 27, 2013	Substantially Equivalent	International Biophysics Corporation
K121170	RESIN 11	Jul 13, 2012	Substantially Equivalent	Respinnovation Sas
K103176	FREQUENCER	Jan 26, 2011	Substantially Equivalent	Dymedso, Inc.
K100749	FREQUENCER MODEL V2X	Aug 31, 2010	Substantially Equivalent	Dymedso, Inc.
K063645	FREQUENCER, MODEL 1001	Mar 15, 2007	Substantially Equivalent	Dymedso, Inc.
K060439	LUNG FLUTE	Jun 22, 2006	Substantially Equivalent	Medical Acoustics, LLC
K053248	SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL	Dec 01, 2005	Substantially Equivalent	Electromed, Inc.
K051383	THE INCOURAGE SYSTEM	Jun 17, 2005	Substantially Equivalent	Respiratory Technologies, Incorporated
K040367	MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 2000EZ	Apr 07, 2004	Substantially Equivalent	Electromed, Inc.
K031876	ELECTRO FLO PERCUSSOR, MODEL 5000	Nov 21, 2003	Substantially Equivalent	Med Systems
K024309	THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104	Feb 21, 2003	Substantially Equivalent	Advanced Respiratory
K012928	ABI VEST AIRWAY CLEARANCE SYSTEM	Oct 09, 2001	Substantially Equivalent	Advanced Respiratory
K993629	ABI VEST AIRWAY CLEARANCE SYSTEM	Jan 21, 2000	Substantially Equivalent	American Biosystems, Inc.
K982889	MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000	Jun 01, 1999	Substantially Equivalent	Electromed, Inc.
K974849	X-AIR-CISER	Aug 06, 1998	Substantially Equivalent	Hougen Mfg., Inc.
K972859	FLUTTER D	Jun 05, 1998	Substantially Equivalent	Bradstreet Clinical Research Assoc., Inc.
K965192	THAIRAPY VEST SYSTEM	Jun 24, 1997	Substantially Equivalent	American Biosystems, Inc.
K946083	FLUTTER(R)	Mar 13, 1995	Substantially Equivalent	Bradstreet Clinical Research Assoc., Inc.
K931988	3P (PULMONARY PERCUSSIVE PACK)	Oct 28, 1994	Substantially Equivalent	Delta Medical Manuf, Inc.
K936121	THAIRAPY SYSTEM	Aug 02, 1994	Substantially Equivalent	American Biosystems, Inc.
K940986	FLUTTER(R)	May 24, 1994	Substantially Equivalent	Varioraw SA
K913014	EMS PERCUSSOR	Oct 23, 1991	Substantially Equivalent	Engineered Medical Systems
K901026	MJ PERCUSSOR(TM)	Mar 15, 1990	Substantially Equivalent	Merced Medical, Inc.
K892862	FLEX-CUP PERCUSSOR	May 25, 1989	Substantially Equivalent	Life Design Systems, Inc.
K882604	PULMO-PATTY	Jan 04, 1989	Substantially Equivalent	Tower Stopper, Inc.
K884098	THAIRAPY(TM) BRONCHIAL DRAINAGE SYSTEM, MODEL 101	Dec 16, 1988	Substantially Equivalent	American Biosystems, Inc.
K883899	MANUAL PERCUSSOR CUPS	Dec 13, 1988	Substantially Equivalent	Medical Components, Inc.
K880597	THUMPER MODEL P-1000	Mar 29, 1988	Substantially Equivalent	Micro Tek Engineering
K863658	SALTER LABS 3000 SERIES PERCUSSORS	Oct 06, 1986	Substantially Equivalent	Salter Labs
K860510	NEONATE PERCUSSOR	Feb 20, 1986	Substantially Equivalent	Ballard Medical Products
K855129	NEOCUSSOR (MASSAGER, BATTERY) POWERED	Jan 23, 1986	Substantially Equivalent	General Physiotherapy, Inc.
K853965	NEOGUARD CHEST PERCUSSOR	Dec 03, 1985	Substantially Equivalent	Cas Medical Systems, Inc.
K842608	INFANT PERCUSSOR PA-010	Jul 23, 1984	Substantially Equivalent	Alpha Medical Systems
K821265	PNEUMOPULSSOR (PPS II)	Jul 26, 1982	Substantially Equivalent	Strom Corp.
K821570	PNEUMO PULSSOR III	Jun 03, 1982	Substantially Equivalent	Strom Corp.
K813438	PNEUMO PULSSOR	Dec 29, 1981	Substantially Equivalent	Strom Corp.
K812803	INFANT PERCUSSOR #5534	Dec 03, 1981	Substantially Equivalent	Hudson Oxygen Therapy Sales Co.
K812151	MJ NEONATAL PERCUSSOR	Aug 25, 1981	Substantially Equivalent	Cussionair Therapy Products, Inc.
K812166	PERCUSSOR	Aug 18, 1981	Substantially Equivalent	Dhd Medical Products Div. Diemolding Corp.
K802646	HAND PERCUSSOR CUP #65210	Nov 12, 1980	Substantially Equivalent	B & F Medical Products, Inc.
K802399	MODEL 2500 PNEUMATIC PERCUSSOR	Oct 23, 1980	Substantially Equivalent	Medical Equipment Development Co., Inc.
K801982	THE MCSHIRLEY PERCUSSOR	Sep 16, 1980	Substantially Equivalent	Mcshirley Products, Inc.
K800713	MJ PERCUSSOR	Apr 10, 1980	Substantially Equivalent	Cussionair Therapy Products, Inc.
K790675	5300 PERCUSSOR	Apr 18, 1979	Substantially Equivalent	Hudson Oxygen Therapy Sales Co.
K771876	ARGYLE PEOCUSSOR SYSTEM	Oct 28, 1977	Substantially Equivalent	Sherwood Medical Industries