# K212644: Aura Storm

- Pathway: 510(k) (Traditional)
- Applicant: Invictus Lighting
- Decided: May 26, 2022 after 279 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; 3 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)
- K200500: Molekule Air Pro RX, Molekule, Inc. (2020) Summary page 5.
- K202339: Molekule Air Mini, Molekule Air Mini +, Molekule, Inc. (2021) Summary page 5.

## Most influential descendants
- K232642: AirKEE T900 (2024), 0 descendants of its own
- K232933: AirKEE P900 (2024), 0 descendants of its own
- K222702: RGS; RGS Mini (2023), 0 descendants of its own

## Indications for use
The Aura Storm air purifier is a device intended for medical purposes that is used to capture and destroy bacteria and viruses in the air through the multi-stage filtration system and exposure to ultraviolet radiation. The Aura Storm air purifier has been demonstrated to destroy the following bacteria: Staphylococcus albicans, Staphylococcus aureus, and Escherichia Coli; and virus: A/PR8/34 HINI virus entrained on the filter of the subject device under the following exposure conditions: Average Maximum log reduction / entrainment time (minutes) at Fan Speed 4. Room Temperature test: Log 4 (99.99%) / 60 minutes. Average Maximum log reduction / entrainment time (minutes) at Fan Speed 1. Room Temperature test: Log 4 (99.99%) / 120 minutes.

Source page: https://510kreport.com/device/K212644
Methodology: https://510kreport.com/methodology