Prodose AAD System
510(k) K030747
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK030747 | Date22 Apr 2004 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- CAF
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5630
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Prodose AAD System is an Adaptive Airway Device Nebulizer (Product Code CAF), designed to deliver inhaled medications, including antibiotics, to patients. It operates as a portable, battery-powered device that adapts airflow to optimize drug deposition in the respiratory tract. This system is classified under the FDA’s regulatory category for Class II devices, requiring special controls to ensure safety and effectiveness. Its primary function is to enhance the efficiency of aerosolized drug delivery through controlled nebulization.
The Prodose AAD System is supplied as a reusable medical device, intended for use in clinical and homecare settings. It requires no sterilization between uses but must be cleaned and maintained according to manufacturer guidelines to prevent contamination. The device is not MRI-compatible and should not be used in magnetic resonance environments. Authorized for marketing via an FDA 510(k) clearance (K030747), it adheres to regulatory standards for Class II nebulizers, ensuring compliance with performance and safety requirements.
Other devices from Profile Therapeutics Plc
Questions
AI-generated answers, 20 Sep 2026
What types of medications can the Prodose AAD System deliver, and why is it designed this way?
The Prodose AAD System is specifically designed to deliver inhaled medications, including antibiotics, to patients. Its adaptive airflow technology optimizes drug deposition in the respiratory tract, improving the efficiency of aerosolized treatments. This is particularly useful for conditions requiring precise medication delivery to the lungs, such as chronic respiratory infections or obstructive airway diseases.
Is the Prodose AAD System intended for use in both hospital and home settings, and how does this affect its design?
Yes, the Prodose AAD System is supplied for use in both clinical (hospital) and homecare settings. Its portable, battery-powered design makes it suitable for mobility, allowing patients to use it outside of a hospital environment. The device’s reusable nature and lack of sterilization requirement between uses align with practical needs for homecare, while still meeting stringent cleaning and maintenance guidelines to ensure safety.
How should I clean and maintain the Prodose AAD System to ensure it remains safe and functional?
The Prodose AAD System is reusable but requires regular cleaning and maintenance as outlined by the manufacturer to prevent contamination. While it does not need sterilization between uses, proper disinfection and upkeep are critical to avoid cross-infection risks. Always follow the manufacturer’s instructions for cleaning protocols to ensure optimal performance and safety.
Can the Prodose AAD System be used in environments with magnetic resonance imaging (MRI) machines, and why?
No, the Prodose AAD System is explicitly stated as not MRI-compatible. This means it should never be used in or near magnetic resonance environments, as the magnetic fields could interfere with the device’s operation or pose safety risks to the patient. Always verify the surroundings before use.
What regulatory pathway was followed for the FDA clearance of the Prodose AAD System, and what does this mean for its safety?
The Prodose AAD System received FDA clearance through an Abbreviated 510(k) pathway (K030747), meaning it was determined to be substantially equivalent to a legally marketed predicate device. This classification places it in FDA’s Class II regulatory category, requiring special controls to ensure safety and effectiveness. The clearance process ensures compliance with performance and safety standards for nebulizers, validating its design and functionality for clinical use.