The Vest Airway Clearance System
FDA 510(k) K142482 · Hill-Rom Services Private Limited
510(k) numberK142482
Submission
- Device name
- The Vest Airway Clearance System
- Applicant
- Hill-Rom Services Private Limited
Singapore, SG - Received
- September 4, 2014
- Decision date
- May 7, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BYI – Percussor, Powered-Electric
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5665
- Specialty
- Anesthesiology
Other 510(k)s with product code BYI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252849 | AffloVest® Mobile Airway Clearance TherapyBYI · Traditional | Tactile Medical | 04/30/2026SE |
| K250860 | BreatheBand® (Model 1000)BYI · Traditional | Exemplar Medical, LLC | 10/02/2025SE |
| K242063 | LibAirty Airway Clearance SystemBYI · Traditional | Synchrony Medical , Ltd. | 12/19/2024SE |
| K240959 | Respiratory Muscle TrainerBYI · Traditional | Chongqing Moffy Innovation Technology Co., Ltd. | 12/18/2024SE |
| K233441 | The Vest APX System (PVAPX1)BYI · Traditional | Baxter Healthcare Corportation | 03/22/2024SE |
| K222496 | Electromed SmartVest Airway Clearance SystemBYI · Special | Electromed, Inc. | 11/18/2022SE |
| K201490 | Electro Flo 6 Airway Clearance SystemBYI · Traditional | Med Systems, Inc. | 02/12/2021SE |
| K203209 | AirPhysio Positive Expiratory Pressure (PEP) DeviceBYI · Traditional | Airphysio Pty, Ltd. | 01/15/2021SE |
| K173603 | Monarch Airway Clearance SystemBYI · Traditional | Hill-Rom Holdings, Inc. | 10/24/2018SE |
| K163378 | Monarch Airway Clearance SystemBYI · Traditional | Hill-Rom Services Pte, Ltd. | 03/17/2017SE |
Questions and answers
When was The Vest Airway Clearance System cleared by the FDA?
The Vest Airway Clearance System (K142482) received a 510(k) decision of Substantially Equivalent on May 7, 2015, 245 days after the submission was received.
What is the product code of K142482?
The FDA product code is BYI – Percussor, Powered-Electric, a Class II (moderate risk) device regulated under 21 CFR 868.5665.