BYI · Class II · 21 CFR 868.5665

FDA Product Code BYI: Percussor, Powered-electric

Leading manufacturers include Hill-Rom Holdings, Inc., Med Systems, Inc. and Airphysio Pty, Ltd..

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

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 →