# K211194: Molekule Air Pro

- Pathway: 510(k) (Traditional)
- Applicant: Molekule, Inc.
- Decided: Aug 20, 2021 after 121 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.
3 later devices descend from it; 2 cite it directly.
0 of 10 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 4.

## Most influential descendants
- K213753: Purgo (2022), 1 descendant of its own
- K221540: Synexis Sphere Rx (2023), 0 descendants of its own
- K223328: Purgo (2022), 0 descendants of its own

## Indications for use
The Molekule Air Pro air purifier is a device intended for medical purposes that is used to capture 95% of particulate matter and destroy bacteria, mold, and viruses by exposure to ultraviolet radiation when operated in Auto Mode Standard or manual mode at fan speed 2 or higher. The Molekule Air Pro air purifier has been demonstrated to entrain and destroy the following bioaerosols under the following exposure/working conditions:

Source page: https://510kreport.com/device/K211194
Methodology: https://510kreport.com/methodology