Airdog X8 Air Purifier (KJ800F-X8)

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K240696 ↗

FDA Product Code

FRF

Device Class

Class II

Regulation

21 CFR Part 880.5045

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• What types of airborne contaminants does the Airdog X8 Air Purifier target in healthcare settings?

  The Airdog X8 Air Purifier is designed to reduce particulate matter, volatile organic compounds (VOCs), and microbial pollutants from recirculated air in general hospital environments. It is classified under 21 CFR 880.5045 as a medical recirculating air cleaner, ensuring it addresses common indoor air quality concerns in clinical spaces.

• Is the Airdog X8 Air Purifier intended for single-use or reusable applications in hospitals?

  The Airdog X8 is explicitly described as a reusable medical-grade air purifier, meaning it is built for continuous use in controlled hospital environments. Unlike single-use devices, it requires maintenance and cleaning protocols to sustain performance over time, though no specific sterility requirements are mentioned in the regulatory submission.

• How is the Airdog X8 Air Purifier regulated, and what does its FDA clearance status indicate?

  The device holds FDA 510(k) clearance (K240696) under a Special 510(k) review, classified as Substantially Equivalent to a predicate device. It also complies with the Medical Devices Directive (MDD) in the EU. This clearance confirms it meets U.S. safety and effectiveness standards for Class II medical devices—specifically for use in general hospital settings to improve recirculated air quality.

• Are there multiple models or sizes available for the Airdog X8 Air Purifier, or is it a single-unit solution?

  The provided data lists multiple registration numbers (e.g., 3003007759, 3017406271, etc.) under the device name, which may indicate variations in FEI numbers (Foreign Entity Identification) or regional compliance registrations rather than distinct physical models. However, no explicit details on sizes, power outputs, or model-specific features are included. For precise sizing or model options, contact the manufacturer directly.

• What storage or environmental conditions should be considered for the Airdog X8 Air Purifier in a hospital?

  While the device is designed for continuous use in controlled hospital environments, the regulatory submission does not specify storage conditions (e.g., temperature, humidity) or MRI compatibility. Since it is reusable and intended for long-term operation, proper ventilation and access to power should be ensured. For optimal performance, follow manufacturer guidelines for maintenance and placement away from direct heat or moisture sources.