Electromed SmartVest Airway Clearance System
FDA 510(k) K222496 · Electromed, Inc.
510(k) numberK222496
Submission
- Device name
- Electromed SmartVest Airway Clearance System
- Applicant
- Electromed, Inc.
New Prague, MN, US - Received
- August 18, 2022
- Decision date
- November 18, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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|---|---|---|---|
| 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 |
| 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 |
| K142482 | The Vest Airway Clearance SystemBYI · Traditional | Hill-Rom Services Private Limited | 05/07/2015SE |
More from Hill-Rom Services Private Limited
| 510(k) | Device | Decision |
|---|---|---|
| K132794 | Smartvest Airway Clearance SystemBYI · Special | 12/19/2013SE |
| K053248 | Smartvest Airway Clearance System, Model TLBYI · Traditional | 12/01/2005SE |
| K040367 | Medpulse Respiratory Vest System, Model 2000EZBYI · Special | 04/07/2004SE |
| K982889 | Medpulse Respiratory Vest System, Model 1000BYI · Traditional | 06/01/1999SE |
| K990813 | RehcorISD · Traditional | 04/12/1999SE |
Questions and answers
When was Electromed SmartVest Airway Clearance System cleared by the FDA?
Electromed SmartVest Airway Clearance System (K222496) received a 510(k) decision of Substantially Equivalent on November 18, 2022, 92 days after the submission was received.
What is the product code of K222496?
The FDA product code is BYI – Percussor, Powered-Electric, a Class II (moderate risk) device regulated under 21 CFR 868.5665.