AirLife Infant Heated Wire Circuit— 510(k) K151303
Substantially EquivalentCare Fusion
FDA 510(k) clearance K151303 for AirLife Infant Heated Wire Circuit, Substantially Equivalent on 2016-01-21. Applicant: Care Fusion. Device class: 2.
Clearance details
- Applicant
- Care Fusion
- Product code
- Code BZE
- Device class
- Class 2
- Regulation
- 21 CFR 868.5270
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vernon Hills, IL, US
Recent devices under product code BZE
view all- K252066 — inspired Heated Breathing Circuit (510-008) +3 more
- K253322 — Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78 Infant Circuit, HUD99060KIT / Dri-Tech with 78 Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60 Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44 Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel)
- K243244 — Heated Breathing Tube
- K241268 — Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)
- K234032 — Hudson RCI Dri-Tech Breathing Circuits +6 more
More clearances from Care Fusion
view allAdverse events under product code BZE
product code BZE- Death
- 4
- Malfunction
- 910
- Other
- 1
- Total
- 915
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K151303
K-number listed on FDA's recall record- Z-1697-2025 — 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, high-flow circuit (>4 L/min) Component: No. a conduit for respiratory gas between the patient and a ventilator.
- Z-1698-2025 — 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, high-flow circuit (>4 L/min) Contains AH165 Circuit, AH290 Chamber Component: No. a conduit for respiratory gas between the patient and a ventilator.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151303.
Data sourced from openFDA. This site is unofficial and independent of the FDA.