BreatheBand® (Model 1000)
FDA 510(k) K250860 · Exemplar Medical, LLC
510(k) numberK250860
Submission
- Device name
- BreatheBand® (Model 1000)
- Applicant
- Exemplar Medical, LLC
Kansas City, MO, US - Received
- March 21, 2025
- Decision date
- October 2, 2025
- 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
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| 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 |
| K142482 | The Vest Airway Clearance SystemBYI · Traditional | Hill-Rom Services Private Limited | 05/07/2015SE |
Questions and answers
When was BreatheBand® (Model 1000) cleared by the FDA?
BreatheBand® (Model 1000) (K250860) received a 510(k) decision of Substantially Equivalent on October 2, 2025, 195 days after the submission was received.
What is the product code of K250860?
The FDA product code is BYI – Percussor, Powered-Electric, a Class II (moderate risk) device regulated under 21 CFR 868.5665.