Airsonett Airshower Air 3
by Airsonett, Inc. FDA registration: Sweden 510(k)
510(k) K081062 Product code FRF
Overview
The Airsonett Airshower Air 3 is a Medical Recirculating Air Cleaner, classified as a Class II device under FDA regulation 880.5045. It is designed to remove airborne particles from controlled environments, ensuring a high degree of particulate filtration for medical applications requiring clean air conditions.
This portable, mobile device is intended for use in general hospital settings and operates as a recirculating air cleaner. It is supplied as a reusable system and has received FDA 510(k) clearance under the Traditional pathway, with a decision date of November 7, 2008. The device is not classified as single-use or MRI-safe, and no specific sterility or storage requirements are noted in the regulatory data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK081062 | Date7 Nov 2008 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Airsonnett Airshower Air 3
- 510(k) Number
- FDA Product Code
- FRF
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5045
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Airsonett AB
Questions
What types of environments is the Airsonett Airshower Air 3 designed to clean and why is it considered portable?
The Airsonett Airshower Air 3 is designed for general hospital settings where maintaining clean air conditions is critical. It is classified as a Medical Recirculating Air Cleaner, meaning it removes airborne particles from controlled indoor spaces to reduce contamination risks. The device is described as portable and mobile, allowing it to be moved between rooms or areas within a facility, making it versatile for temporary or flexible clean-air needs in clinical settings.
Is the Airsonett Airshower Air 3 intended for single-use or can it be reused in a clinical setting?
The Airsonett Airshower Air 3 is explicitly described as a reusable system, meaning it is not designed for single-use. This classification aligns with its role as a recirculating air cleaner, where durability and repeated use are essential for maintaining clean-air environments in hospital settings. No specific cleaning or maintenance instructions are provided in the regulatory data, but typical reusable medical devices require proper disinfection between uses.
What regulatory pathway was followed for FDA clearance of the Airsonnet Airshower Air 3, and what does that mean for its use?
The Airsonnet Airshower Air 3 received FDA 510(k) clearance under the Traditional pathway, meaning it was determined to be substantially equivalent to a legally marketed predicate device. This clearance indicates that the device meets FDA standards for safety and effectiveness as a Class II Medical Recirculating Air Cleaner (regulated under 880.5045) and can be legally marketed and used in general hospital settings as intended. The decision date was November 7, 2008.
Are there any special storage requirements for the Airsonnet Airshower Air 3, and how should it be handled to ensure optimal performance?
The regulatory data does not specify any unique sterility or storage requirements for the Airsonnet Airshower Air 3, as it is a reusable device rather than a sterile consumable. However, since it operates in clinical environments, it should be stored in a clean, dry location away from direct sunlight or extreme temperatures to preserve its functionality. Proper maintenance, as outlined in the manufacturer’s instructions, will be critical to ensure continued performance in filtering airborne particles.
What does the product code (FRF) and advisory committee classification (HO) indicate about the intended use of this device?
The product code (FRF) categorizes the Airsonnet Airshower Air 3 under Hospital Operations (HO), which is an administrative classification for devices used in general hospital settings—not an indication of clinical use. Similarly, the advisory committee (HO) refers to the General Hospital Panel, which reviews submissions for hospital-related devices. Neither implies a specific medical procedure or clinical application but confirms the device’s role in supporting clean-air conditions within hospitals.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K081062