# K222702: RGS; RGS Mini

- Pathway: 510(k) (Traditional)
- Applicant: Genesis Air, Inc.
- Decided: Jun 2, 2023 after 268 days
- Product code: FRA (Purifier, Air, Ultraviolet, Medical)
- Device class: 2
- Regulation: 21 CFR 880.6500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K023830 (2003). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212644: Aura Storm, Invictus Lighting (2022) Summary page 5.

## Indications for use
The RGS / RGS mini is a medical ultraviolet air purifier that is intended for medical purposes. It is used to destroy bacteria in the air by exposure to ultraviolet radiation. The RGS and RGS mini have demonstrated the ability to eliminate Staphylococcus Epidermidis, Bacteriophage MS2, and Escherichia Coli in the air of the test chamber in 60 minutes under the following conditions. The device with model number RGS and a high fan speed of 600 CFM when tested against Staphylococcus Epidermidis (gram positive) had a log reduction of 4.0 PFU/ft^3. The device with model number RGS and a high fan speed of 600 CFM when tested against Bacteriophage MS2 had a log reduction of 4.02 PFU/ft^3.The device with model number RGS and a high fan speed of 600 CFM when tested against Escherichia Coli had a log reduction of 4.24 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Staphylococcus Epidermidis (gram positive) had a log reduction of 4.04 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Bacteriophage MS2 had a log reduction of 4 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Escherichia Coli had a log reduction of 4.0 PFU/ft^3. This device is not intended for use in areas with a sterile field or controlled air flow.

Source page: https://510kreport.com/device/K222702
Methodology: https://510kreport.com/methodology