# K223328: Purgo

- Pathway: 510(k) (Special)
- Applicant: Aeroclean Technologies, Inc.
- Decided: Nov 30, 2022 after 30 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: 8 generations back to K023830 (2003). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213753: Purgo, Aeroclean Technologies, LLC (2022) Summary page 4.

## 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: Methicillin resistant Staphylococcus epidermidis — 4.6 (45) at normal speed Bacillus globigii endospore — 4.1 (60) at normal speed Escherichia coli — 5.4 (45) at normal speed MS2 bacteriophage — 5.4 (60) at normal speed SARS-CoV-2, BA.2 Omicron — 4.7 (60) at normal speed Phi-X174 bacteriophage — 4.4 (45) at normal speed Aspergillus spore — 4.3 (90) at normal speed

Source page: https://510kreport.com/device/K223328
Methodology: https://510kreport.com/methodology