# K213753: Purgo

- Pathway: 510(k) (Traditional)
- Applicant: Aeroclean Technologies, LLC
- Decided: Jun 1, 2022 after 183 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: 7 generations back to K023830 (2003). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211194: Molekule Air Pro, Molekule, Inc. (2021) Summary page 4.
- K200500: Molekule Air Pro RX, Molekule, Inc. (2020) Summary page 4.

## Most influential descendants
- K223328: Purgo (2022), 0 descendants of its own

## Indications for use
Pūrgo is a combination UV and air filtration device, equipped with UV-C LEDs and a True HEPA filter intended for the reduction of bacteria, virus, fungal spores, and particles in air for use in medical facilities and other indoor spaces. Pūrgo is non-sterile. Pūrgo has been demonstrated to remove the following organisms under the following exposure conditions:

Source page: https://510kreport.com/device/K213753
Methodology: https://510kreport.com/methodology