BYI — Percussor, Powered-Electric Class II
FDA Device Classification
Classification Details
- Product Code
- BYI
- Device Class
- Class II
- Regulation Number
- 868.5665
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
| K250860 | exemplar medical | BreatheBand® (Model 1000) | October 2, 2025 |
| K242063 | synchrony medical | LibAirty Airway Clearance System | December 19, 2024 |
| K240959 | chongqing moffy innovation technology co | Respiratory Muscle Trainer | December 18, 2024 |
| K233441 | baxter healthcare corportation | The Vest APX System (PVAPX1) | March 22, 2024 |
| K222496 | electromed | Electromed SmartVest Airway Clearance System | November 18, 2022 |
| K201490 | med systems | Electro Flo 6 Airway Clearance System | February 12, 2021 |
| K203209 | airphysio pty | AirPhysio Positive Expiratory Pressure (PEP) Device | January 15, 2021 |
| K173603 | hill-rom holdings | Monarch Airway Clearance System | October 24, 2018 |
| K163378 | hill-rom services pte | Monarch Airway Clearance System | March 17, 2017 |
| K142482 | hill-rom services private limited | The Vest Airway Clearance System | May 7, 2015 |
| K132794 | electromed | SMARTVEST AIRWAY CLEARANCE SYSTEM | December 19, 2013 |
| K121587 | cheen houng ent. co. | BREATH SHAKE | November 22, 2013 |
| K122480 | international biophysics corporation | INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST | March 27, 2013 |
| K121170 | respinnovation | RESIN 11 | July 13, 2012 |
| K103176 | dymedso | FREQUENCER | January 26, 2011 |
| K100749 | dymedso | FREQUENCER MODEL V2X | August 31, 2010 |
| K063645 | dymedso | FREQUENCER, MODEL 1001 | March 15, 2007 |
| K060439 | medical acoustics | LUNG FLUTE | June 22, 2006 |
| K053248 | electromed | SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL | December 1, 2005 |
| K051383 | respiratory technologies, incorporated | THE INCOURAGE SYSTEM | June 17, 2005 |