BYI · Class II · 21 CFR 868.5665

FDA Product Code BYI: Percussor, Powered-electric

Leading manufacturers include Hudson Oxygen Therapy Sales Co., Dhd Medical Products Div. Diemolding Corp. and Cas Medical Systems, 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 May 25, 1989
FLEX-CUP PERCUSSOR
K892862
Life Design Systems, Inc.
Anesthesiology · 37d
Cleared Dec 13, 1988
MANUAL PERCUSSOR CUPS
K883899
Medical Components, Inc.
Anesthesiology · 89d
Cleared Oct 06, 1986
SALTER LABS 3000 SERIES PERCUSSORS
K863658
Salter Labs
Anesthesiology · 18d
Cleared Feb 20, 1986
NEONATE PERCUSSOR
K860510
Ballard Medical Products
Anesthesiology · 9d
Cleared Dec 03, 1985
NEOGUARD CHEST PERCUSSOR
K853965
Cas Medical Systems, Inc.
Anesthesiology · 68d
Cleared Dec 03, 1981
INFANT PERCUSSOR #5534
K812803
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 58d
Cleared Aug 18, 1981
PERCUSSOR
K812166
Dhd Medical Products Div. Diemolding Corp.
Anesthesiology · 19d
Cleared Apr 18, 1979
5300 PERCUSSOR
K790675
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 9d
Cleared Oct 28, 1977
ARGYLE PEOCUSSOR SYSTEM
K771876
Sherwood Medical Industries
Anesthesiology · 24d

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 →