BYI — Percussor, Powered-Electric Class II
FDA product code BYI covers "Percussor, Powered-Electric", a Class II medical device regulated under 21 CFR 868.5665. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K252849 | tactile medical | AffloVest® Mobile Airway Clearance Therapy | April 30, 2026 |
| 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 |