510(k) · Cleared
ClearedMolekule Air Pro RX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Molekule, Inc. · FRA Purifier, Air, Ultraviolet, Medical
Cleared on Apr 15, 2020 as substantially equivalent to K161468 (Transformair, LLC, 2017) after a 47-day review. Its family tree reaches back 4 generations to 2003. 11 later devices descend from it.
- Decided
- Apr 15, 2020
- Review
- 47 days
- Class
- Class II
- Product code
- FRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K023830 (2003). 11 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK023830 Airocide TI02Kes Science & Technology, Inc. · 2003
- 3 generations backK033448 Electro-Optical Air Sterilizer with IonizerJohn Mfg., Ltd. · 2004
- 2 generations backK052732 Abracair Air Cleaner, Model QTZ300-60; Abracair Air Cleaner, Model…Abracair, Inc. · 2006
- 1 generation backK161468 Transformair Indoor Air PurifierTransformair, LLC · 2017
- This deviceK200500 Molekule Air Pro RXMolekule, Inc. · 2020
- Descendant · cites it directly · 9 of its ownK202339 Molekule Air Mini, Molekule Air Mini +Molekule, Inc. · 2021
- Descendant · cites it directly · 3 of its ownK212644 Aura StormInvictus Lighting · 2022
- Descendant · 2 generations on · 3 of its ownK211194 Molekule Air ProMolekule, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK213753 PurgoAeroclean Technologies, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK232642 AirKEE T900Healkee Medical Pte, Ltd. · 2024
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K202339Molekule Air Mini, Molekule Air Mini +Molekule, Inc. · 2021 · cites it directly9descendants
- K212644Aura StormInvictus Lighting · 2022 · cites it directly3descendants
- K211194Molekule Air ProMolekule, Inc. · 2021 · 2 generations on3descendants
- K213753PurgoAeroclean Technologies, LLC · 2022 · cites it directly1descendant
- K232642AirKEE T900Healkee Medical Pte, Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K023830 | Airocide TI02 | Kes Science & Technology, Inc. | 2003 | — |
| −3 | K033448 | Electro-Optical Air Sterilizer with Ionizer | John Mfg., Ltd. | 2004 | — |
| −2 | K052732 | Abracair Air Cleaner, Model QTZ300-60; Abracair Air Cleaner, Model TI 100-30P | Abracair, Inc. | 2006 | — |
| −1 | K161468 | Transformair Indoor Air Purifier | Transformair, LLC | 2017 | — |
| 0 (this device) | K200500 | Molekule Air Pro RX | Molekule, Inc. | 2020 | — |
| +1 | K202339 | Molekule Air Mini, Molekule Air Mini + | Molekule, Inc. | 2021 | — |
| +1 | K212644 | Aura Storm | Invictus Lighting | 2022 | — |
| +2 | K211194 | Molekule Air Pro | Molekule, Inc. | 2021 | — |
| +1 | K213753 | Purgo | Aeroclean Technologies, LLC | 2022 | — |
| +2 | K232642 | AirKEE T900 | Healkee Medical Pte, Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 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 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 |
|---|---|---|---|
| * | K161468 | Transformair Indoor Air PurifierSummary page 5…ifier CLASSIFICATION NAMES: Purifier, Air, Ultraviolet, Medical REVIEW PANEL: General Hospital PRODUCT CODE: FRA PREDICATE DEVICE(S): Transformair Indoor Air Purifier, K161468 K200500 Page 2 of 9 Molekule Inc. is the current holder of the Transformair 510(k)… | 2017 |
| † | K052732 | Abracair Air Cleaner, Model QTZ300-60; Abracair Air Cleaner, Model TI 100-30P | 2006 |
What descends from it? (11)
See all 114 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 17 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K202339 (Molekule, Inc., 2021) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K161468.
How does its category compare?
All FRA devicesFRA Purifier, Air, Ultraviolet, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Molekule Air Pro RX air purifier is a device intended for medical purposes that is used
to destroy bacteria and viruses in the air by exposure to ultraviolet radiation.
The core technology components of the Molekule Air Pro RX air purifier have been
demonstrated to destroy the following MS2 bacteriophage bioaerosol entrained on the filter of
the subject device under the following exposure conditions:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200500 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200500: Molekule Air Pro RX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200500
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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