Airlife Nasal Continuous Positive Airway Pressure (ncpap) Sytem Driver
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K051226 FDA 510(k)
- FDA Product Code
- BZD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5905 FDA 510(k)
- Regulation Number
- 868.5905 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Airlife Nasal Continuous Positive Airway Pressure (NCPAP) System Driver is a device used in hospital settings to deliver continuous positive airway pressure (CPAP) through a circuit and generator to newborns and infants. It is intended to treat spontaneously breathing newborns and infants with Respiratory Distress Syndrome (RDS) or those recovering from RDS under the supervision of qualified personnel. The system functions by providing a prescribed level of CPAP via a patient interface consisting of either nasal prongs or a mask.
The device is supplied as part of a system that includes a generator and patient interface components. It is used in hospital settings and is regulated as a Class II medical device with FDA 510(k) clearance. The device is not described as MRI safe, and no information is provided regarding sterility, single-use or reusable status, or specific storage requirements.
Frequently asked questions
What is the Airlife Nasal NCPAP System Driver used for?
The Airlife Nasal NCPAP System Driver is used to deliver continuous positive airway pressure (CPAP) to spontaneously breathing newborns and infants with Respiratory Distress Syndrome (RDS) or those recovering from RDS. It supports treatment under the supervision of qualified personnel in hospital settings by providing a prescribed level of CPAP via nasal prongs or a mask interface.
How is the Airlife Nasal NCPAP System Driver supplied and what components does it include?
The device is supplied as part of a system that includes a generator and patient interface components. It is designed for use in hospital settings and functions by delivering CPAP through a circuit to the patient interface, which consists of either nasal prongs or a mask. The system driver itself is the unit that generates and regulates the pressure.
Is the Airlife Nasal NCPAP System Driver intended for single-use or reuse, and is it sterile?
The provided device data does not specify whether the Airlife Nasal NCPAP System Driver is sterile, single-use, or reusable. No information is given regarding sterility, single-use status, or reprocessing instructions. Users should consult the manufacturer’s labeling or instructions for use for details on handling, cleaning, and reuse policies.
What are the storage requirements for the Airlife Nasal NCPAP System Driver?
The device data does not include any specific storage requirements for the Airlife Nasal NCPAP System Driver. No information is provided about temperature, humidity, or environmental conditions for storage. Users should refer to the manufacturer’s instructions for proper storage conditions to maintain device integrity and function.
What regulatory pathway was used for the Airlife Nasal NCPAP System Driver?
The Airlife Nasal NCPAP System Driver received FDA 510(k) clearance, indicating it was found substantially equivalent to a legally marketed predicate device. The clearance type is traditional, and the device is classified as a Class II medical device under regulation number 868.5905 with product code BZD. The decision was made on November 17, 2005, under the anesthesiology advisory committee review.
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. Sources consulted: Airlife Nasal Continuous Positive Airway Pressure (Ncpap) Sytem Driver ..., Cardinal Health AirLife 006900 Operator's Maintenance Manual, Cardinal Health AirLife nCPAP Hardware Service Manual
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K051226 | Class II | Active |
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Manufacturer
- Manufacturer
- Cardinalhealth
Sources (1)
- FDA 510(k) K051226 24 fields · synced Oct 6, 2026