# K202339: Molekule Air Mini, Molekule Air Mini +

- Pathway: 510(k) (Traditional)
- Applicant: Molekule, Inc.
- Decided: Feb 23, 2021 after 190 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.
9 later devices descend from it; 3 cite it directly.
0 of 15 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 5.

## Most influential descendants
- K212644: Aura Storm (2022), 3 descendants of its own
- K211194: Molekule Air Pro (2021), 3 descendants of its own
- K213753: Purgo (2022), 1 descendant of its own
- K232642: AirKEE T900 (2024), 0 descendants of its own
- K232933: AirKEE P900 (2024), 0 descendants of its own

## Indications for use
The Molekule Air Mini air purifier is a device intended for medical purposes that is used to capture 95% of particulate matter and destroy bacteria and viruses by exposure to ultraviolet radiation. The Molekule Air Mini air purifier has been demonstrated to destroy the following MS2 bacteriophage bioaerosol entrained on the filter of the subject device under the following exposure/working conditions: The Molekule Air Mini + air purifier is a device intended for medical purposes that is used to capture 95% of particulate matter and destroy bacteria and viruses by exposure to ultraviolet radiation when operated in manual mode at fan speed 3 or higher. The Molekule Air Mini + air purifier has been demonstrated to destroy the following MS2 bacteriophage bioaerosol entrained on the filter of the subject device under the following exposure/working conditions:

Source page: https://510kreport.com/device/K202339
Methodology: https://510kreport.com/methodology