AirLife Infant Heated Wire Circuit
FDA 510(k) clearance K151303 · decided 2016-01-21
Clearance details
- K-number
- K151303
- Device name
- AirLife Infant Heated Wire Circuit
- Applicant
- Care Fusion
- Decision
- Substantially Equivalent
- Date received
- 2015-05-18
- Decision date
- 2016-01-21
- Days to decision
- 248 days
- Clearance type
- Traditional
- Product code
- BZE
- Device class
- 2
- Regulation number
- 868.5270
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Vernon Hills, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: recall (Z-1697-2025) | Vyaire Medical | 2025-05-09 |
| Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: recall (Z-1698-2025) | Vyaire Medical | 2025-05-09 |