510(k) · Cleared
ClearedAura Storm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invictus Lighting · FRA Purifier, Air, Ultraviolet, Medical
Cleared on May 26, 2022 as substantially equivalent to K200500 (Molekule, Inc., 2020) and 1 other predicate after a 279-day review. Its family tree reaches back 6 generations to 2003. 3 later devices descend from it.
- Decided
- May 26, 2022
- Review
- 279 days
- Class
- Class II
- Product code
- FRA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K023830 (2003). 3 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK023830 Airocide TI02Kes Science & Technology, Inc. · 2003
- 5 generations backK033448 Electro-Optical Air Sterilizer with IonizerJohn Mfg., Ltd. · 2004
- 4 generations backK052732 Abracair Air Cleaner, Model QTZ300-60; Abracair Air Cleaner, Model…Abracair, Inc. · 2006
- 3 generations backK161468 Transformair Indoor Air PurifierTransformair, LLC · 2017
- 2 generations backK200500 Molekule Air Pro RXMolekule, Inc. · 2020
- 1 generation backK202339 Molekule Air Mini, Molekule Air Mini +Molekule, Inc. · 2021
- This deviceK212644 Aura StormInvictus Lighting · 2022
- Descendant · cites it directly · 0 of its ownK232642 AirKEE T900Healkee Medical Pte, Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK232933 AirKEE P900Healkee Medical Pte, Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK222702 RGS; RGS MiniGenesis Air, Inc. · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K023830 | Airocide TI02 | Kes Science & Technology, Inc. | 2003 | — |
| −5 | K033448 | Electro-Optical Air Sterilizer with Ionizer | John Mfg., Ltd. | 2004 | — |
| −4 | K052732 | Abracair Air Cleaner, Model QTZ300-60; Abracair Air Cleaner, Model TI 100-30P | Abracair, Inc. | 2006 | — |
| −3 | K161468 | Transformair Indoor Air Purifier | Transformair, LLC | 2017 | — |
| −2 | K200500 | Molekule Air Pro RX | Molekule, Inc. | 2020 | — |
| −1 | K202339 | Molekule Air Mini, Molekule Air Mini + | Molekule, Inc. | 2021 | — |
| 0 (this device) | K212644 | Aura Storm | Invictus Lighting | 2022 | — |
| +1 | K232642 | AirKEE T900 | Healkee Medical Pte, Ltd. | 2024 | — |
| +1 | K232933 | AirKEE P900 | Healkee Medical Pte, Ltd. | 2024 | — |
| +1 | K222702 | RGS; RGS Mini | Genesis Air, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FRA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FRA device
- #1 K200500 Molekule Air Pro RXscore 12.1 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K200500 | Molekule Air Pro RXSummary page 5…et, Medical • Review Panel: General Hospital • Product Code: FRA PREDICATE DEVICE(S): Molekule Air Pro RX Air Purifier, K200500 Molekule Air Mini Air Purifier, K202339 DEVICE DESCRIPTION: The Aura Storm is a multi-stage UV-C air purifier that deli… | 2020 |
| * | K202339 | Molekule Air Mini, Molekule Air Mini +Summary page 5…General Hospital • Product Code: FRA PREDICATE DEVICE(S): Molekule Air Pro RX Air Purifier, K200500 Molekule Air Mini Air Purifier, K202339 DEVICE DESCRIPTION: The Aura Storm is a multi-stage UV-C air purifier that delivers air purification for rooms up to 2700… | 2021 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K232642 (Healkee Medical Pte, Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K200500.
How does its category compare?
All FRA devicesFRA Purifier, Air, Ultraviolet, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · FRA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRA
205in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRA
No recall names FRA since 2007.
Adverse event reports per year · FRA
2in 2024
MAUDE reports naming product code FRA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 5 | 190 | 0 | 1 |
| 2022 | 4 | 175 | 0 | 1 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 4 | 205 | 0 | 2 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (115 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212644 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212644: Aura Storm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212644
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026