# K232645: Airgle Room Air Purifier

- Pathway: 510(k) (Traditional)
- Applicant: Airgle Corporation
- Decided: Feb 16, 2024 after 170 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: 6 generations back to K023830 (2003). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202339: Molekule Air Mini, Molekule Air Mini +, Molekule, Inc. (2021) Summary page 7.

## Indications for use
The Airgle Room Air Purifier is a free standing, air purifying device utilizing germicidal ultraviolet light (UV-C wavelengths near 254nm) intended for inactivation of indoor airborne aerosols including bacteria and virus in medical facilities and occupied spaces. The Airgle® Air Purifier has been demonstrated to destroy MS2 bacteriophage bioaerosol entrained on the filter of the subject device in the following exposure/working conditions: Test Item(s) Test Results (Average Maximum Log Reduction / Entrainment Time at Fan Speed 5) MS2 Bacteriophage Model AG300: >4.0 Logs / 120 minutes Model AG600: >4.0 Logs / 120 minutes Model AG900: >4.0 Logs / 120 minutes

Source page: https://510kreport.com/device/K232645
Methodology: https://510kreport.com/methodology