Purgo Air Purifier, Ultraviolet, Medical
by Aeroclean Technologies, Inc.
510(k) K223328
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK223328 | Date30 Nov 2022 | 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- Withdrawn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
- Full name
- Purgo
- 510(k) Number
- FDA Product Code
- FRA
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6500
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Purgo is a medical-grade ultraviolet air purifier designed to disinfect airborne pathogens in healthcare environments. It employs germicidal UV-C LED technology to inactivate microorganisms, including bacteria and viruses, within the air supply. This device is classified as a Class II medical device under FDA regulations, targeting airborne contamination control in general hospital settings. Its primary function is to reduce bioaerosol load through continuous ultraviolet disinfection.
The Purgo is supplied as a reusable medical device intended for installation in hospital ventilation systems or as a standalone unit. It operates under regulatory authorization via FDA 510(k) clearance (K223328) and is classified under product code FRA. The device requires proper installation and maintenance in accordance with manufacturer guidelines, with no indication of single-use or sterile packaging. Compliance with FDA standards for Class II devices ensures its suitability for general hospital use, though MRI safety or sterility claims are not specified.
Other devices from Aeroclean Technologies, LLC
Questions
AI-generated answers, 1 Oct 2026
What is the Purgo designed to do in healthcare environments?
The Purgo is a medical-grade ultraviolet air purifier that uses germicidal UV-C LED technology to inactivate airborne microorganisms, such as bacteria and viruses, within hospital ventilation systems. Its primary purpose is to reduce the bioaerosol load by continuously disinfecting the air supply, helping to maintain cleaner air in general hospital settings.
Is the Purgo a single-use or reusable device?
The Purgo is intended for reuse. It is supplied as a reusable medical device and requires proper installation and maintenance in accordance with the manufacturer’s guidelines. Unlike single-use devices, it is designed to be integrated into hospital ventilation systems or used as a standalone unit for ongoing air disinfection.
How is the Purgo installed and maintained?
The Purgo is designed for installation in hospital ventilation systems or as a standalone unit. Maintenance follows manufacturer-provided guidelines to ensure optimal performance and compliance with FDA standards for Class II devices. Regular upkeep is necessary to sustain its effectiveness in reducing airborne pathogens.
Does the Purgo come with sterile packaging?
No, the Purgo is not supplied in sterile packaging. It is classified as a reusable medical device, and sterility is not a specified feature. Proper installation and maintenance are required to ensure its safe and effective operation in healthcare environments.
What regulatory approval does the Purgo hold?
The Purgo has received FDA 510(k) clearance (K223328) and is classified as a Class II medical device under product code FRA. This authorization confirms its substantial equivalence to a predicate device and suitability for use in general hospital settings to control airborne contamination.