510(k) K151303 ยท BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
AirLife Infant Heated Wire Circuit
| Applicant | Care Fusion, Vernon Hills IL, US |
| Decision | Substantially Equivalent, Jan 21, 2016 |
| Received | May 18, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151303
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 9, 2025 | Vyaire Medical Brand Name: AirLife
Product Name: AirLife Infant Heated Wire Circuit
Model/Catalog Number: AH165
Software Version: N/A
Product Description: AirLife Infant Heated Wire Circuit dual-limb, dual-heat, hig Open, Classified |
BZE | None listed |
| May 9, 2025 | Vyaire Medical Brand Name: AirLife
Product Name: AirLife Infant Heated Wire Circuit
Model/Catalog Number: AH265
Software Version: N/A
Product Description: AirLife Infant Heated Wire Circuit Kit Dual-limb, Dual-heat, Open, Classified |
BZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.