510(k) · Cleared
ClearedRGS; RGS Mini
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genesis Air, Inc. · FRA Purifier, Air, Ultraviolet, Medical
Cleared on Jun 2, 2023 as substantially equivalent to K212644 (Invictus Lighting, 2022) after a 268-day review. Its family tree reaches back 7 generations to 2003.
- Decided
- Jun 2, 2023
- Review
- 268 days
- Class
- Class II
- Product code
- FRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K023830 (2003). No later device cites it as a predicate yet.
- Root · 7 generations backK023830 Airocide TI02Kes Science & Technology, Inc. · 2003
- 6 generations backK033448 Electro-Optical Air Sterilizer with IonizerJohn Mfg., Ltd. · 2004
- 5 generations backK052732 Abracair Air Cleaner, Model QTZ300-60; Abracair Air Cleaner, Model…Abracair, Inc. · 2006
- 4 generations backK161468 Transformair Indoor Air PurifierTransformair, LLC · 2017
- 3 generations backK200500 Molekule Air Pro RXMolekule, Inc. · 2020
- 2 generations backK202339 Molekule Air Mini, Molekule Air Mini +Molekule, Inc. · 2021
- 1 generation backK212644 Aura StormInvictus Lighting · 2022
- This deviceK222702 RGS; RGS MiniGenesis Air, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K023830 | Airocide TI02 | Kes Science & Technology, Inc. | 2003 | — |
| −6 | K033448 | Electro-Optical Air Sterilizer with Ionizer | John Mfg., Ltd. | 2004 | — |
| −5 | K052732 | Abracair Air Cleaner, Model QTZ300-60; Abracair Air Cleaner, Model TI 100-30P | Abracair, Inc. | 2006 | — |
| −4 | K161468 | Transformair Indoor Air Purifier | Transformair, LLC | 2017 | — |
| −3 | K200500 | Molekule Air Pro RX | Molekule, Inc. | 2020 | — |
| −2 | K202339 | Molekule Air Mini, Molekule Air Mini + | Molekule, Inc. | 2021 | — |
| −1 | K212644 | Aura Storm | Invictus Lighting | 2022 | — |
| 0 (this device) | K222702 | RGS; RGS Mini | Genesis Air, Inc. | 2023 | — |
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 K212644 Aura Stormscore 13.9 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K212644 | Aura StormSummary page 5…emarket Submission RGS / RGS mini 5. Legally Marketed Predicate Device(s) K212644, Aura Storm, Invictus Lighting No reference devices were used in this submission. 6. Indication for Use Statement The RGS / RGS… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
- None of the 7 ancestors has a recall.
- 2 other devices also cite its predicate K212644.
How does its category compare?
All FRA devicesFRA Purifier, Air, Ultraviolet, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 RGS / RGS mini is a medical ultraviolet air purifier that is intended for medical purposes. It is used to destroy bacteria in the air by exposure to ultraviolet radiation. The RGS and RGS mini have demonstrated the ability to eliminate Staphylococcus Epidermidis, Bacteriophage MS2, and Escherichia Coli in the air of the test chamber in 60 minutes under the following conditions. The device with model number RGS and a high fan speed of 600 CFM when…
Read the full statement (242 words)
The RGS / RGS mini is a medical ultraviolet air purifier that is intended for medical purposes. It is used to destroy
bacteria in the air by exposure to ultraviolet radiation.
The RGS and RGS mini have demonstrated the ability to eliminate Staphylococcus Epidermidis, Bacteriophage MS2, and
Escherichia Coli in the air of the test chamber in 60 minutes under the following conditions.
The device with model number RGS and a high fan speed of 600 CFM when tested against Staphylococcus Epidermidis
(gram positive) had a log reduction of 4.0 PFU/ft^3. The device with model number RGS and a high fan speed of 600
CFM when tested against Bacteriophage MS2 had a log reduction of 4.02 PFU/ft^3.The device with model number RGS
and a high fan speed of 600 CFM when tested against Escherichia Coli had a log reduction of 4.24 PFU/ft^3. The device
with model number RGS mini and a high fan speed of 500 CFM when tested against Staphylococcus Epidermidis (gram
positive) had a log reduction of 4.04 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500
CFM when tested against Bacteriophage MS2 had a log reduction of 4 PFU/ft^3. The device with model number RGS
mini and a high fan speed of 500 CFM when tested against Escherichia Coli had a log reduction of 4.0 PFU/ft^3.
This device is not intended for use in areas with a sterile field or controlled air flow.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K222702 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222702: RGS; RGS Mini.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222702
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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