AirLife DuoTherm Humidification System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K231380 FDA 510(k)
- FDA Product Code
- BTT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5450 FDA 510(k)
- Regulation Number
- 868.5450 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The AirLife DuoTherm Humidification System is a respiratory gas humidifier designed for direct patient interface applications. It delivers heated, humidified gas to patients during anesthesia and respiratory therapy to maintain airway moisture and reduce the risk of complications such as tracheobronchitis or mucosal dryness.
This system is intended for use in clinical settings such as operating rooms and intensive care units. It is supplied as a reusable device, requiring sterilization between uses, and is classified as a Class II medical device under FDA regulations. The system operates with various model-specific configurations, as indicated by the listed FEI numbers, and complies with the Medical Device Directive (MDD) and FDA 510(k) clearance for substantial equivalence in the Anesthesiology specialty.
Frequently asked questions
What clinical settings is the AirLife DuoTherm Humidification System intended for use in, and why is this important?
The AirLife DuoTherm Humidification System is designed for use in clinical settings such as operating rooms and intensive care units. This is important because these environments require precise control of respiratory gas humidity to maintain patient airway moisture, reduce the risk of complications like tracheobronchitis, and ensure safe anesthesia and respiratory therapy delivery.
Is the AirLife DuoTherm Humidification System single-use or reusable, and what does this mean for maintenance?
The AirLife DuoTherm Humidification System is a reusable device, which means it must be sterilized between uses. This requires adherence to proper sterilization protocols to ensure patient safety and device functionality, distinguishing it from single-use devices that do not require reprocessing.
How many different model configurations are available for the AirLife DuoTherm Humidification System, and how can I identify them?
The system is available in multiple model-specific configurations, each identified by unique FEI numbers (e.g., 3002807293, 3002808440, etc.). These variations allow for flexibility in clinical applications, but the exact model must be confirmed against the listed FEI numbers to ensure compatibility with your facility’s needs.
What regulatory pathways has the AirLife DuoTherm Humidification System followed, and what does this imply for its use?
The device has obtained FDA 510(k) clearance and complies with the Medical Device Directive (MDD), demonstrating substantial equivalence in the Anesthesiology specialty. This implies it meets U.S. and EU regulatory standards for safety and performance, ensuring it can be legally used in those markets for its intended purpose—delivering heated, humidified gas to patients.
Why is the AirLife DuoTherm Humidification System classified as a Class II medical device under FDA regulations?
The classification as a Class II device reflects its role in directly interfacing with patients to deliver respiratory gas while maintaining critical humidity levels. This classification requires additional controls beyond general controls (like labeling and manufacturing practices) to ensure its safety and effectiveness, as it directly impacts patient airway health during anesthesia and therapy.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K231380 | Class II | Active |
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Manufacturer
- Manufacturer
- Vyaire Medical, Inc.
Sources (2)
- FDA 510(k) K231380 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026