Molekule Air Pro
The Molekule Air Pro filters room air and uses ultraviolet light with a catalytic filter to reduce microorganisms captured in the device. Its medical-purpose indication covers capture of…
The Molekule Air Pro filters room air and uses ultraviolet light with a catalytic filter to reduce microorganisms captured in the device. Its medical-purpose indication covers capture of particulate matter and destruction of bacteria, mould and viruses when used in Auto Mode Standard or at manual fan speed 2 or higher.
A fan draws air through lower vents, across the PECO filter exposed to UV-A light and out through upper vents. Light initiates a reaction at the catalytic surface that generates reactive molecules which oxidise microorganisms held on the filter.
Listed Item
The Molekule Air Pro air purifier is a device intended for medical purposes that is used to capture 95% of particulate matter and destroy bacteria, mold, and viruses by exposure to ultraviolet radiation when operated in Auto Mode Standard or manual mode at fan speed 2 or higher.
Controls
A touchscreen and LCD provide local control, with an app offering another interface. The particulate sensor supports an automatic mode that adjusts fan speed according to detected particle levels. The device is used in homes or medical facilities.
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Ajax Medical Equipment Co Ltd | Guangzhou | Guangdong | Manufacturer | 13 |
| Shenzhen Airgle Corporation Limited | Shenzhen | Guangdong | Manufacturer | 4 |
Record
| Listed by | Molekule Group, Inc., United States |
|---|---|
| FDA product code | FRA |
| Device type | Purifier, Air, Ultraviolet, Medical |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6500 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K211194 |
| Record published | 2021-09-02 |
| Record revised | 2023-10-18 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SQ2P-US | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Airgle | Airgle Corporation | 10 |
| RGF-BioControls | RGF Environmental Group, Inc | 9 |
| Aerobiotix | Aerobiotix USA | 5 |
| ADS | Guangzhou Ajax Medical Equipment Co Ltd | 5 |
| Molekule Air Mini + | Molekule Group, Inc. | 2 |
| Molekule | Molekule Group, Inc. | 1 |
| The Pyure Company | The Pyure Company Inc | 1 |
| ActivePure Medical Guardian | Activepure Medical LLC | 1 |
| Purgo | Molekule Group, Inc. | 1 |
| RGS mini | Genesis AIR, Inc. | 1 |
| Medical Guardian | Aerus Medical, LLC | 1 |
| RGS | Genesis AIR, Inc. | 1 |
Showing 12 of 13. All products under Purifier, Air, Ultraviolet, Medical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K211194 | 2021-08-20 |
| K202339 | 2021-02-23 |
| K200500 | 2020-04-15 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.