# K200500: Molekule Air Pro RX

- Pathway: 510(k) (Traditional)
- Applicant: Molekule, Inc.
- Decided: Apr 15, 2020 after 47 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: 4 generations back to K023830 (2003). 4 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161468: Transformair Indoor Air Purifier, Transformair, LLC (2017) Summary page 5.

## Most influential descendants
- K202339: Molekule Air Mini, Molekule Air Mini + (2021), 9 descendants of its own
- 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

## Indications for use
The Molekule Air Pro RX air purifier is a device intended for medical purposes that is used to destroy bacteria and viruses in the air by exposure to ultraviolet radiation. The core technology components of the Molekule Air Pro RX air purifier have been demonstrated to destroy the following MS2 bacteriophage bioaerosol entrained on the filter of the subject device under the following exposure conditions:

Source page: https://510kreport.com/device/K200500
Methodology: https://510kreport.com/methodology