LibAirty Airway Clearance System
FDA 510(k) clearance K242063 · decided 2024-12-19
Clearance details
- K-number
- K242063
- Device name
- LibAirty Airway Clearance System
- Applicant
- Synchrony Medical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-07-15
- Decision date
- 2024-12-19
- Days to decision
- 157 days
- Clearance type
- Traditional
- Product code
- BYI
- Device class
- 2
- Regulation number
- 868.5665
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Or Yehuda, IL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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| Electromed SmartVest Airway Clearance System (K222496) | Electromed, Inc. | 2022-11-18 |
| Electro Flo 6 Airway Clearance System (K201490) | Med Systems, Inc. | 2021-02-12 |
| AirPhysio Positive Expiratory Pressure (PEP) Device (K203209) | Airphysio Pty, Ltd. | 2021-01-15 |
| Monarch Airway Clearance System (K173603) | Hill-Rom Holdings, Inc. | 2018-10-24 |
| Monarch Airway Clearance System (K163378) | Hill-Rom Services Pte, Ltd. | 2017-03-17 |
| The Vest Airway Clearance System (K142482) | Hill-Rom Services Private Limited | 2015-05-07 |
| SMARTVEST AIRWAY CLEARANCE SYSTEM (K132794) | Electromed, Inc. | 2013-12-19 |
| BREATH SHAKE (K121587) | Cheen Houng Ent. Co. , Ltd. | 2013-11-22 |
Recalls involving this device
No recalls on record reference this clearance.