AirLife Autofill Humidification Chamber
FDA 510(k) clearance K160764 · decided 2016-08-25
Clearance details
- K-number
- K160764
- Device name
- AirLife Autofill Humidification Chamber
- Applicant
- Carefusion 2200, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-03-21
- Decision date
- 2016-08-25
- Days to decision
- 157 days
- Clearance type
- Traditional
- Product code
- BTT
- Device class
- 2
- Regulation number
- 868.5450
- 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 |
|---|---|---|
| Infant AirLife single-limb, continuous-flow circuit (Model AH132) containing AirLife Humid recall (Z-0343-2018) | Vyaire Medical | 2018-01-24 |
| Infant AirLife Dual-,limb, dual-heat, high-flow circuit (Model AH265) with AirLife Humidif recall (Z-0344-2018) | Vyaire Medical | 2018-01-24 |
| Adult Air-Life single-limb circuit (Model AH202) with AirLife Humidification Chamber, Mode recall (Z-0345-2018) | Vyaire Medical | 2018-01-24 |
| Adult AirLife dual-limb, dual-heat circuit (Model AH280) with AirLife Humidification Chamb recall (Z-0346-2018) | Vyaire Medical | 2018-01-24 |