Medical Guardian
The Aerus Medical Guardian, model F170A, is an air-treatment device intended to reduce specified bacteria, viruses, fungal spores and bacterial spores from air in a temperature-controlled…
The Aerus Medical Guardian, model F170A, is an air-treatment device intended to reduce specified bacteria, viruses, fungal spores and bacterial spores from air in a temperature-controlled professional healthcare environment. The FDA indication names this exact model.
The filing lists Staphylococcus epidermidis, Erwinia herbicola, MS2, Phi-X174, Aspergillus niger and Bacillus globigii. It specifies an environment of 70 to 71 degrees Fahrenheit and 40 to 45 percent relative humidity, and separately reports test results at stated conditions.
Test Conditions
The FDA table reports average reductions after 60 minutes at 72 degrees Fahrenheit and 50 percent relative humidity. For the named model it lists 5.95 log reduction for Staphylococcus epidermidis and 5.58 for MS2.
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 | Aerus Medical, LLC, United States |
|---|---|
| FDA product code | FRA |
| Device type | Purifier, Air, Ultraviolet, Medical |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6500 |
| 510(k) | K201220 |
| Record published | 2021-04-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| F170A | 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 |
| RGS | Genesis AIR, Inc. | 1 |
| Molekule Air Pro | Molekule Group, Inc. | 1 |
Showing 12 of 13. All products under Purifier, Air, Ultraviolet, Medical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201220 | 2020-06-17 |
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.