# K202766: EOS Air Cleaner

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Ajax Medical Equipment Co., Ltd.
- Decided: Jun 11, 2021 after 263 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: 5 generations back to K023830 (2003). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200500: Molekule Air Pro RX, Molekule, Inc. (2020) Summary page 4.

## Indications for use
EOS Air Cleaner is a device intended for medical purposes that is used to destroy bacteria and viruses in the air by exposure to ultraviolet radiation in general medical environment. The core technology components of the EOS Air Cleaner have been demonstrated to destroy MS2 bacteriophage bioaerosol entrained on the filter to achieve an average 4 log reduction over 4 hours in a 30 cubic meter chamber.

Source page: https://510kreport.com/device/K202766
Methodology: https://510kreport.com/methodology